Iso13485 Jobs

The Maintenance Lead role at G&F Precision Molding Inc. provides first-level supervision for the manufacturing department within the life science and medical device sector. The position requires onsite presence in Fiskdale, MA, with primary duties including orchestrating daily production operations, managing preventative maintenance schedules to maximize machine utilization, and coaching technicians to ensure safety and quality compliance. This opportunity appeals to candidates seeking a collaborative environment focused on innovation and customer-centric solutions, offering significant professional growth through tuition reimbursement and development assistance. The role supports a culture of excellence where employees contribute to challenging projects from concept to execution while benefiting from a comprehensive rewards package including health coverage and paid time off.

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.

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.

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 six-month onsite contract role within the Quality Calibration Lab supports the medical device industry by maintaining inspection, measurement, and test equipment. The technician performs calibration, verification, and adjustment of electrical and mechanical instruments while ensuring compliance with FDA and ISO standards. Key responsibilities include managing field service equipment, documenting results for audit readiness, and coordinating with vendors to reduce calibration backlogs. The position offers the opportunity to work in a regulated environment with a focus on quality assurance and operational efficiency in San Diego.

The Quality Engineer role at Norman Noble involves supporting a team dedicated to manufacturing life-sustaining medical devices. Key responsibilities include leading process improvement projects, managing quality system documentation and records, and collaborating with customers and suppliers on validation activities and audits. The position requires analyzing data to drive decisions and ensuring compliance with industry standards like ISO 13485. This opportunity is appealing due to the company's entrepreneurial culture where individual contributions are highly visible, the access to state-of-the-art facilities, and the focus on continuous growth through high-tech problem-solving. The role is based on-site within the company's manufacturing facilities.

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 Medical Device Engineer role at Cresilon involves leading the design, development, and testing of innovative hemostatic medical devices in Brooklyn, New York. Key responsibilities include formulating polymeric materials, defining product requirements, managing design history files, and ensuring compliance with FDA and ISO regulations. The position offers the appeal of working on life-saving technology within a collaborative, hands-on culture that values scientific excellence and rapid innovation. This full-time, on-site position requires a multidisciplinary approach, partnering with cross-functional teams to move projects from concept to launch while mentoring staff and contributing to the company's mission of saving lives.

This Scientist I role within AbbVie's Injectables Device Development team focuses on advancing combination products from concept to commercial launch. The position involves designing and executing laboratory studies, supporting design transfer and industrialization activities, and performing 3D CAD development alongside statistical data analysis. The role offers the appeal of working at the intersection of engineering and biopharmaceuticals to deliver life-changing therapies, featuring a collaborative multi-disciplinary environment. The position requires up to 25% travel and is based in a setting that values complex problem-solving and continuous improvement.