Project Coordinator - Product Change Control
Not Disclosed•ContractorOn-site
location_on981, Pizarro Lane, Foster City, San Mateo County, California, 94404, United States
About the Company
Our client is a world leader in life sciences and biotechnology, dedicated to advancing the field through innovation in drug-device combination products. They operate in a highly regulated environment where product quality and supply continuity are paramount to patient safety and public health.
About the Role
This Project Coordinator position serves as a critical operational hub within the commercial product lifecycle. The role exists to ensure seamless execution of change control activities, bridging the gap between engineering, quality, regulatory affairs, and manufacturing teams. You will be the driving force behind maintaining rigorous risk management documentation and coordinating post-market surveillance reporting. In this capacity, you will partner with cross-functional stakeholders to navigate complex product changes, ensuring all initiatives are executed with precision and compliance.
Application Instructions
Interested candidates should submit their resume to kavitha@dawarconsulting.com or hr@dawarconsulting.com.
Work location
Work model: On-site
981, Pizarro Lane, Foster City, San Mateo County, California, 94404, United States
Foster City, California
Key Responsibilities
- check_circleInitiate, coordinate, and close change control records for product and manufacturing changes
- check_circleSupport design and development changes for drug-device combination products
- check_circleCoordinate implementation of approved changes across manufacturing sites
- check_circlePrepare and maintain post-market surveillance reports and risk management summaries
- check_circleUpdate and maintain risk management files in compliance with regulations
- check_circleSupport complaint investigations, root cause analysis, and documentation activities
- check_circleCollaborate with cross-functional teams to drive project execution
- check_circleMaintain documentation within quality systems and ensure regulatory compliance
- check_circleTrack project timelines, deliverables, and change implementation activities
Requirements
- verifiedBachelor's degree in Engineering, Life Sciences, Quality, or related discipline
- verified3–5 years of experience in medical device, combination product, pharmaceutical, or regulated manufacturing environments
- verifiedExperience managing change controls, engineering changes, or product lifecycle activities
- verifiedKnowledge of FDA, ISO 13485, cGMP, and medical device regulations
- verifiedExperience with risk management activities, including FMEA and risk file maintenance
- verifiedFamiliarity with complaint investigations, CAPA, and quality systems processes
Nice to Have
Experience supporting drug-device combination products. Experience with Design Controls, Design History Files (DHF), and product development documentation. Hands-on experience with Veeva Vault, Agile PLM, Windchill, TrackWise, MasterControl, or similar systems. Knowledge of post-market surveillance and risk management reporting.
Benefits & Perks
check_circleMedical, Dental, and Vision insurancecheck_circlePaid Sick leavecheck_circle401K retirement plan
Similar Job Opportunities
Skills, education and keywords
Skills: Change Control, Design Controls, Risk Management, Iso 13485, Fda 21 CFR Part 820, CGMP, Capa, Complaint Investigation, DHF, Fmea.
Education: Bachelor's degree in Engineering, Life Sciences, Quality, or related discipline required.
Frequently asked questions about Project Coordinator - Product Change Control at DAWAR CONSULTING INC
What does a Project Coordinator - Product Change Control at DAWAR CONSULTING INC do?expand_more
In this Project Coordinator - Product Change Control at DAWAR CONSULTING INC role, you will initiate, coordinate, and close change control records for product and manufacturing changes; support design and development changes for drug-device combination products; coordinate implementation of approved changes across manufacturing sites; and prepare and maintain post-market surveillance reports and risk management summaries.
What are the requirements for this Project Coordinator - Product Change Control role?expand_more
DAWAR CONSULTING INC is looking for candidates who meet the following requirements: Bachelor's degree in Engineering, Life Sciences, Quality, or related discipline; 3–5 years of experience in medical device, combination product, pharmaceutical, or regulated manufacturing environments; Experience managing change controls, engineering changes, or product lifecycle activities; Knowledge of FDA, ISO 13485, cGMP, and medical device regulations; Experience with risk management activities, including FMEA and risk file maintenance; and Familiarity with complaint investigations, CAPA, and quality systems processes.
Where is the Project Coordinator - Product Change Control role at DAWAR CONSULTING INC located?expand_more
Project Coordinator - Product Change Control at DAWAR CONSULTING INC is based in 981, Pizarro Lane, Foster City, San Mateo County, California, 94404, United States. This is a on-site role.
Is this Project Coordinator - Product Change Control job remote, hybrid, or on-site?expand_more
DAWAR CONSULTING INC has listed this Project Coordinator - Product Change Control role as on-site.
How much experience is required for this Project Coordinator - Product Change Control role?expand_more
Project Coordinator - Product Change Control at DAWAR CONSULTING INC typically requires 3–5 years of relevant experience at the mid level level.
What skills do you need for the Project Coordinator - Product Change Control role at DAWAR CONSULTING INC?expand_more
Key skills for Project Coordinator - Product Change Control at DAWAR CONSULTING INC include Change Control; Design Controls; Risk Management; Iso 13485; Fda 21 CFR Part 820; CGMP; Capa; and Complaint Investigation.
What education is required for Project Coordinator - Product Change Control at DAWAR CONSULTING INC?expand_more
Educational requirements for this role: Bachelor's degree in Engineering, Life Sciences, Quality, or related discipline required.
What category does the Project Coordinator - Product Change Control role belong to?expand_more
Project Coordinator - Product Change Control at DAWAR CONSULTING INC is part of the scientific & qa job category on Recrutus.
About DAWAR CONSULTING INC
DAWAR CONSULTING INC operates within the IT Services and IT Consulting sector, based in Newark, California. The firm specializes in delivering comprehensive technology and business consulting solutions designed to address complex organizational challenges. By focusing on strategic workforce solutions, project delivery, and robust IT support, the company assists clients in optimizing their operational efficiency and technological infrastructure.
The organization serves a diverse range of clients seeking expert guidance in navigating the digital landscape. Through its dedicated team, DAWAR CONSULTING INC facilitates seamless project execution and provides the necessary technical backing to ensure business continuity. The company's approach emphasizes reliability and professional expertise, positioning it as a key partner for entities requiring specialized IT services. Located in Newark, California, the firm maintains a focused presence in the region while delivering value to its client base through tailored consulting strategies.
Browse more roles: All DAWAR CONSULTING INC jobs, scientific & qa jobs on Recrutus.