Quality Engineer Jobs

FirstPRO is now accepting resumes for a Quality Engineer on behalf of a client of ours in biopharmaceutical. You will be working with the medical device team to support lab quality assurance activities for equipment qualification, test method development, and design verification and validation testing. This position will report to the Director of Medical Device Quality. The role is hybrid requiring an on-site minimum of 3 days per week in New Haven, CT.

Principal Responsibilities

• Reviews and approves characterization, feasibility studies, test method development/validations, and equipment qualification activities (FAT/SAT/IQ/OQ/PQ) in compliance oversight per FDA 21CFR 820.30 and ISO 13485.
• Responsible to ensure device testing, method development, method transfers and troubleshooting, and all related documentation is compliant with applicable regulations.
• Provide Quality oversight for the development, review, and approval of key Design History File deliverables including Verification and Validation Protocols and Reports, Risk Management deliverables, Transfer Plans, Design Reviews, Design History File management, and supporting operational procedures.
• Provide Quality oversight to ensure quality processes are in place for the qualification of lab equipment and fixtures prior to use for GxP activity.

Qualifications

• Experience with quality engineering principles such as basic statistics, sampling calculations, incoming and 1st article inspection, and measurement system analysis.
• Bachelor’s in Science or Engineering degree required
• Experience with design controls V&V testing, Design of Experiments, systems engineering is a plus.
• Knowledge of the regulatory and compliance requirements of design control for medical devices and/or combination products.
• Active ASQ CQE, CRE, and /or Six Sigma certification(s) are a plus.
• Experience with hands on root cause investigation of device malfunctions in Prefilled syringes, autoinjectors, on body injectors is a plus.
• Experienced in and good understanding of lab management in GLP environment supporting, ISO13485, ISO11608, and ISO11040.
• 5+ yrs of experience in the pharma or medical device industry

Preference will be given to candidates with an advanced degree with Five (3) or more years of cGLP/GMP experience; consideration will be given to other relevant experience and education in developing mechanical test methods for combination products or working in related roles in Quality Control/Assurance, Design Assurance, Quality Engineering functions supporting design verification and validation of medical devices, or combination products.