Product Quality Engineer

3 days ago

Marlborough, United Kingdom Global Technical Talent Full time

Product Quality Engineer Alternate/Related Job Titles: Risk Management Quality Engineer Post-Market Quality Engineer Medical Device Quality Engineer Location: Marlborough, MA Onsite Flexibility: Position Type: Contract Contract Duration: ~6 months Start: As Soon As Possible Pay Rate: $45 – $70/hr Job Summary The Product Quality Engineer will support risk management activities and product complaint trending by reviewing individual complaint records, assessing associated risk lines and severities from the Risk Management File (RMF), and collaborating with Product Quality Engineering and Post Market Quality Engineering teams. The role ensures risks are properly identified, potential RMF updates are evaluated, and trend analysis is performed in alignment with applicable quality procedures. Key Responsibilities Analyze complaint information to identify hazardous situations and harms reported through complaint data. Evaluate existing Risk Management Files to verify hazardous situations and harms are accurately captured based on complaint information. Perform trend analysis using Statistical Process Control (SPC) per relevant quality procedures. Partner with PQE, PMQE, and Post Market Analytics teams to assess investigation results and determine appropriate updates to the RMF. Conduct assessments and escalate potential documentation or process gaps as required by business needs. Perform additional related activities as reasonably required. Required Experience BS in biomedical engineering, mechanical engineering, or a healthcare‑related discipline. Minimum 1 year of experience in medical devices or another highly regulated industry. Quality Engineering experience preferred. Nice-to-Have Experience Experience authoring and executing risk assessments. Working knowledge of ISO 14971, 21 CFR 803, and 21 CFR 820. Required Skills Strong understanding of ISO 14971 risk management. Familiarity with Quality System Regulations (ISO 13485, 21 CFR 820). Ability to identify hazardous situations and harms using complaint data. Preferred Skills Knowledge of FMEA and risk analysis techniques. Basic medical terminology and anatomy. Understanding of engineering and process terminology. Knowledge of SPC with Minitab (preferred). Additional Skills Detail‑oriented approach with focus on accuracy and compliance. Accountable, reliable, and communicative with timely escalation. Collaborative team mindset, open to feedback and shared goals. Ability to work on cross‑functional project teams and lead critical tasks. Ability to assess written product and project documentation and communicate findings effectively. Physical Demands Ability to sit and use hands to handle or feel objects, tools, or controls. Ability to stand, walk, reach with hands/arms, stoop, kneel, crouch, or crawl.(Reasonable accommodations may be made per ADA.) Benefits Medical, Vision, and Dental Insurance Plans 401k Retirement Fund Job Number: 25-29082#gttic #gttjobs #J-18808-Ljbffr

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