Product Quality Engineer- Medical Device

Product Quality Engineer - Medical Device This range is provided by Collabera. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $40.00/hr - $50.00/hr Direct message the job poster from Collabera. Position Overview The Sr. Product Quality Engineer provides design quality expertise to product development teams, ensuring patient/user safety, customer satisfaction, and organizational success. This role involves leading risk management activities and supporting a broad range of development quality functions. Key Responsibilities Lead and support on-time completion of Design Control deliverables Establish objective, measurable, and verifiable product requirements Plan and execute Design Verification and Validation, including investigations and resolution activities Lead risk management from product concept through commercialization Support test method development and validation Assist with manufacturing process development and qualification for new products and design changes Define component specifications, sampling plans, and vendor qualifications Support biocompatibility and sterilization qualifications Participate in audits and quality system improvement initiatives Support organizational initiatives in Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory compliance Maintain collaborative communication with all levels of employees, contractors, and suppliers Basic Qualifications Bachelor’s degree in Engineering or related technical field Minimum 5 years of experience in R&D, process/manufacturing engineering, or quality, with at least 2 years in product development Experience in medical device regulations and standards Experience in test method development and validation Experience preparing risk assessments, FMEA, and other risk documentation Preferred Qualifications Advanced degree in Engineering or technical field Experience with active implantable medical devices Familiarity with requirements management tools (e.g., DOORS) and problem reporting systems (e.g., JIRA) Working knowledge of statistics applied to verification and validation Benefits medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time, paid sick, and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility Seniority Level Mid-Senior level Employment Type Contract Job Function Engineering and Science Industries Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Collabera by 2x Sign in to set job alerts for “Product Quality Engineer” roles. #J-18808-Ljbffr Collabera