Iso 13485 Jobs

This Principal Engineer role in Technical Operations focuses on leading process development and continuous improvement within radiopharmaceutical manufacturing. The position involves managing Non-Conformance Reports, Corrective and Preventive Actions, and Change Controls to ensure strict adherence to ISO 13485 and 21 CFR 820 regulations. Key responsibilities include creating Master Batch Records, serving as a Subject Matter Expert for cross-functional teams, and driving data analysis to enhance operational efficiency and product quality. The role offers the opportunity to work on complex, high-impact projects that directly support patient care through innovative technical solutions. It is designed for experienced engineers who thrive in a collaborative environment where they can mentor colleagues and independently solve difficult process challenges.

This full-time Engineering Technician role supports injection molding operations within PMC SMART Solutions, a contract manufacturer producing life-saving medical devices and automotive components. The position involves executing mold trials, validating processes, and troubleshooting automation systems to ensure production efficiency. Key responsibilities include assisting with tooling setups, monitoring product quality, and collaborating with cross-functional engineering teams to drive continuous improvement initiatives. The role appeals to candidates seeking hands-on technical work in a regulated, high-impact environment where their contributions directly support critical healthcare and safety products. The position offers a collaborative culture focused on operational excellence and offers opportunities for professional growth within a certified, award-winning organization.

This Director of Operations role leads manufacturing, supply chain, and quality functions for a global leader in precision power electronics and control systems based in Rochester. The position oversees end-to-end production processes including electronics assembly, testing, and box build while managing critical relationships with Tier 1 and Tier 2 suppliers. Key responsibilities include maintaining ISO and industry-specific certifications, implementing Lean and Six Sigma initiatives to drive efficiency, and leading cross-functional teams to ensure compliance with strict regulations in aerospace, medical, and semiconductor sectors. The role appeals to experienced leaders seeking a hands-on player-coach environment where they can directly influence operational excellence and product reliability. The position is primarily onsite with a mix of strategic planning and floor oversight, offering opportunities for professional growth within a high-reliability engineering culture.

The Quality Control Inspector role at Orchid Orthopedic Solutions involves performing receiving, in-process, and final inspections on medical device components within a Swiss-style turning manufacturing environment. Key responsibilities include utilizing precision metrology tools for dimensional and visual testing, maintaining accurate documentation in compliance with FDA and ISO standards, and conducting First Article Inspections. The position offers the appeal of working for a world-leading medical device company with a mission to improve patient lives, providing opportunities for professional growth, comprehensive benefits, and a collaborative culture that values integrity and teamwork. This on-site position in California requires adherence to modified production schedules and supports a diverse, inclusive workplace.

The Program Manager II role leads cross-functional teams within Forj Medical to deliver complex medical device projects on time and within budget. Key responsibilities include managing customer expectations, negotiating contract changes, and coordinating schedules, budgets, and scope across engineering, manufacturing, and supply chain departments. The position requires guiding multiple medium-scale programs while ensuring compliance with FDA and ISO regulations. This opportunity appeals to professionals seeking a dynamic environment where they can drive process improvements and add value to diverse customer products. The role operates in a matrixed organization with a focus on collaboration and independent leadership.

This full-time Operations Technician role on the first shift supports Orchid Orthopedic Solutions, a leading medical device manufacturer specializing in orthopedic implants. The position focuses on precision deburring and inspection of small surgical components using microscopes and hand tools. Key responsibilities include removing rough edges from parts, verifying dimensional accuracy with measuring instruments, and maintaining a clean, organized workspace. The role appeals to individuals who take pride in craftsmanship and want to contribute to life-saving medical products. Orchid offers a structured environment with opportunities for professional growth, comprehensive benefits, and a culture that values integrity and teamwork. This on-site position is located in California.

The Senior Analyst - ISO Security Governance role supports Federal and DoD customers by managing complex information assurance requirements and security governance frameworks. Key responsibilities include performing risk assessments, advising system owners on compliance with NIST and FedRAMP standards, and collaborating with ISSO teams to align organizational policies with federal regulations. The position involves maintaining risk registers, mapping security controls, and recommending enhancements to the security posture. This opportunity appeals to professionals seeking to work with advanced GRC tools in a fast-paced environment while contributing to critical national security initiatives. The role requires a bachelor's degree and seven or more years of experience in security governance, with certifications like CISSP or CISM being advantageous.

This senior analyst role focuses on ISO security governance within a team supporting Federal and Department of Defense customers. The position involves performing complex risk assessments, establishing information assurance requirements, and advising system owners on security policies. Key responsibilities include aligning organizational governance with federal standards such as NIST and FISMA, collaborating with ISSO teams on shared services, and managing governance activities like vendor assessments and risk registers. The role appeals to professionals seeking to apply their expertise in FedRAMP and RMF frameworks within a mission-driven environment. Candidates will work in a fast-paced setting that values initiative and collaboration, requiring strong communication skills to translate technical security concepts into business terms.

This senior analyst role focuses on ISO security governance within a team supporting Federal and Department of Defense customers. The position involves performing complex risk assessments, establishing information assurance requirements, and advising system owners on security policies. Key responsibilities include aligning organizational governance with federal standards such as NIST and FISMA, collaborating with enterprise and project ISSOs, and managing governance activities like vendor assessments and risk registers. The role appeals to professionals seeking to work with advanced security frameworks and tools in a fast-paced environment. It requires strong communication skills to translate technical security language into business terms and offers the opportunity to enhance security posture for high-stakes government contracts.

This senior analyst role focuses on ISO security governance within a team supporting Federal and Department of Defense customers. The position involves conducting complex risk assessments, establishing information assurance requirements, and advising system owners on security policies. Key responsibilities include aligning organizational governance with federal standards such as NIST and FISMA, collaborating with ISSO teams on shared services, and managing governance activities like vendor assessments and risk registers. The role appeals to professionals seeking to leverage their expertise in security frameworks and GRC tools while working in a fast-paced environment. It offers the opportunity to influence security posture for high-stakes government contracts and requires strong communication skills to translate technical requirements into business terms.

This senior analyst role focuses on ISO security governance within a team supporting Federal and Department of Defense customers. The position involves performing complex risk assessments, establishing information assurance requirements, and advising system owners on security policies. Key responsibilities include aligning organizational governance with federal regulations like NIST and FISMA, collaborating with ISSO teams on shared services, and managing governance activities such as vendor assessments and risk registers. The role appeals to professionals seeking to work with advanced security frameworks and tools in a fast-paced environment. It offers the opportunity to apply specialized knowledge in a mission-critical setting while developing solutions for complex security challenges.

This senior analyst role focuses on ISO security governance within a team supporting Federal and Department of Defense customers. The position involves performing complex risk assessments, establishing information assurance requirements, and advising system owners on security policies. Key responsibilities include aligning organizational governance with federal regulations such as NIST and FISMA, collaborating with ISSO teams, and managing governance activities like vendor assessments and risk registers. The role appeals to professionals seeking to leverage their expertise in FedRAMP, RMF, and GRC tools within a fast-paced environment. It offers the opportunity to work with cutting-edge security technologies and requires strong communication skills to translate technical requirements into business terms. The position is based on-site with potential travel requirements.

The Senior Analyst - ISO Security Governance role supports Federal and Department of Defense customers by managing complex information assurance requirements and security governance frameworks. Key responsibilities include performing risk assessments, advising system owners on compliance with NIST and DoD standards, and collaborating with enterprise teams to align security policies with federal regulations. The position involves maintaining governance activities such as vendor assessments and risk registers while recommending enhancements to the security posture. This opportunity appeals to professionals seeking to work with cutting-edge security technologies in a fast-paced environment. The role requires a blend of independent judgment and collaborative teamwork to translate technical security language into business terms. Candidates will engage with shared services and business development teams to ensure robust governance for existing and prospective contracts.

This senior analyst role focuses on ISO security governance within a team supporting Federal and Department of Defense customers. The position involves performing complex risk assessments, establishing information assurance requirements, and advising system owners on security policies. Key responsibilities include aligning organizational governance with federal standards such as NIST and FISMA, collaborating with ISSO teams, and managing governance activities like vendor assessments and risk registers. The role appeals to professionals seeking to work with advanced security frameworks and tools in a fast-paced environment. It offers the opportunity to apply specialized knowledge in a collaborative setting while developing solutions for complex security challenges.

The Senior Analyst - ISO Security Governance role supports Federal and Department of Defense customers by managing complex information assurance requirements and security governance frameworks. Key responsibilities include performing risk assessments, advising system owners on compliance with NIST and DoD standards, and collaborating with enterprise teams to align security policies with federal regulations. The position involves maintaining governance tools, conducting vendor assessments, and translating technical security language into business terms. This opportunity appeals to professionals seeking to work on high-impact government contracts within a collaborative environment that values initiative and complex problem-solving. The role requires a blend of independent judgment and teamwork to navigate a fast-paced, deadline-oriented setting.

The Sr Analyst - ISO Security Governance role supports Federal and DoD customers by managing complex information assurance requirements and security governance frameworks. Key responsibilities include performing risk assessments, advising system owners on security policies, and aligning organizational governance with regulations such as NIST 800-171 and FISMA. The position involves collaborating with Enterprise ISSO teams and business development groups to ensure compliance across shared services and prospective contracts. This opportunity appeals to professionals seeking to work with cutting-edge security technologies in a fast-paced environment. The role requires strong communication skills to translate technical security concepts into business terms and offers the chance to influence strategic security posture for high-stakes government projects.

This senior analyst role focuses on ISO security governance within a team supporting Federal and Department of Defense customers. The position involves performing complex risk assessments, establishing information assurance requirements, and advising system owners on security policies. Key responsibilities include aligning organizational governance with federal regulations like NIST and FISMA, collaborating with ISSO teams on shared services, and managing enterprise risk registers. The role appeals to professionals seeking to apply their expertise in a mission-driven environment with opportunities to influence security posture across critical government systems. Candidates will work in a fast-paced setting requiring strong communication skills to translate technical security concepts into business terms.

The Senior Analyst - ISO Security Governance role supports Federal and DoD customers by managing complex information assurance requirements and security governance frameworks. Key responsibilities include performing detailed risk assessments, advising system owners on compliance with NIST and FedRAMP standards, and collaborating with enterprise teams to align organizational policies with federal regulations. The position involves maintaining governance registers, facilitating vendor assessments, and translating technical security language into business terms. This opportunity appeals to professionals seeking to work with cutting-edge security technologies in a fast-paced environment. The role offers the chance to influence high-level security strategy while developing expertise in federal compliance frameworks. Candidates will work within a collaborative team structure that values initiative and complex problem-solving.

This senior analyst role focuses on ISO security governance within a team supporting Federal and Department of Defense customers. The position involves performing complex risk assessments, establishing information assurance requirements, and advising system owners on security policies. Key responsibilities include aligning organizational governance with federal regulations like NIST and FISMA, collaborating with ISSO teams, and managing governance activities such as vendor assessments and risk registers. The role appeals to candidates seeking to work with advanced security frameworks and tools in a fast-paced environment. It requires strong communication skills to translate technical security concepts into business terms and offers the opportunity to influence security posture for high-stakes government contracts.

The Sr Analyst - ISO Security Governance role supports Federal and DoD customers by managing complex information assurance requirements and security governance frameworks. Key responsibilities include performing risk assessments, advising system owners on policy alignment with NIST and FISMA standards, and collaborating with ISSO teams to maintain compliance across shared services. The position appeals to professionals seeking to leverage expertise in FedRAMP, RMF, and GRC tools within a mission-driven environment. The role requires a blend of independent judgment and teamwork to translate technical security language into business terms, offering opportunities for professional growth in a fast-paced, deadline-oriented setting.

The Senior Analyst - ISO Security Governance role supports Federal and Department of Defense customers by managing complex information assurance requirements and security governance frameworks. Key responsibilities include performing detailed risk assessments, advising system owners on compliance with NIST and DoD standards, and collaborating with enterprise teams to align security policies with federal regulations. The position involves maintaining governance activities such as vendor assessments and risk registers while recommending enhancements to the security posture. This opportunity appeals to professionals seeking to work with cutting-edge security technologies in a fast-paced environment. The role offers the chance to apply expertise in FedRAMP and RMF processes within a collaborative culture that values initiative and complex problem-solving.

This senior analyst role focuses on ISO security governance within a team supporting Federal and Department of Defense customers. The position involves performing complex risk assessments, establishing information assurance requirements, and advising system owners on security policies. Key responsibilities include aligning organizational governance with federal regulations like NIST and FISMA, collaborating with ISSO teams, and managing governance activities such as vendor assessments and risk registers. The role appeals to professionals seeking to work with cutting-edge security technologies in a fast-paced environment. It offers the opportunity to apply specialized knowledge of FedRAMP and RMF frameworks while developing solutions for complex security challenges. The position requires a blend of independent judgment and collaborative teamwork to navigate regulatory demands effectively.

The Lead Manufacturing Quality Specialist role oversees quality assurance processes within the manufacturing department to ensure compliance with industry standards and customer requirements. Key responsibilities include managing the quality team, implementing quality management systems, leading continuous improvement initiatives using Lean and Six Sigma methodologies, and collaborating with engineering and supply chain teams to resolve defects. The position offers a challenging career in the energy sector with opportunities for professional development, a collaborative work environment, and the chance to drive strategic process excellence.

This full-time Quality Lab Technician role is based at ProAmpac's Cincinnati facility and supports the extrusion and quality assurance teams within the flexible packaging industry. The position involves conducting in-process film inspections, performing incoming material testing for resins, and maintaining laboratory equipment calibration in compliance with ISO standards. Key responsibilities include documenting test results, quarantining non-conforming materials, and assisting the QA manager with work instructions and training activities. The role offers a 12-hour day shift schedule with opportunities for advancement in a safety-focused environment that prioritizes employee well-being and provides comprehensive benefits.

This full-time inside sales role supports the growing industrial fasteners division at Lightning Bolt & Supply, a certified manufacturer. The position focuses on processing quotations and orders, evaluating requests for quotes, and maintaining professional communication with customers and vendors via phone and email. Cold calling is not required. The role appeals to candidates seeking a supportive environment with a friendly team culture, offering benefits such as fully employer-paid health insurance, a 1:1 retirement match, and provided lunches. While the position is based in Baton Rouge, Louisiana, qualified out-of-state applicants willing to relocate are encouraged to apply.