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We're looking for a Product Quality Engineer
, working in Pharmaceuticals and Medical Products
industry in 100 College Street, New Haven, Connecticut, 06510, United States
- Develops the design control quality plan in line with applicable regulations for combination products including Planning, Design and Development, Verification, Validation and Transfer
- Provides Quality oversight of the Design and Development Plan, User Requirement Specifications including Target Product Profile, Risk Management Plan, Design History File, and Design Review
- Maintains Product Quality Monographs, Supply Chain Maps, and Device Master Records in compliance with investigational product and commercial marketing applications
- Authors Global Annual Product Quality Review, coordinating with leads of contributing chapters
- Provides lead quality review of CMC sections of Regulatory submissions and response to queries
- Owner of the stability program including ensuring annual commitments are met
- Manages reference standard program with a focus on ensuring supply
- Facilitates Product Specification Committee
- Facilitates global changes with respect to the product and design control
- Supports Health Authority inspections and compliance
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Preferable 10 years cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial
- Combination product and device delivery system experience
- Design for Six Sigma (DFSS) trained and certified a plus
- Demonstrated ability in decision making, problem solving and project management
- Collaborate, negotiate, influence and lead in a matrix organization
- Excellent communication and interpersonal skills
- Proven record in demonstrating agility
- Flexibility to travel in support of the role
- Knowledge of process development and quality systems with a strong business and technical acumen would be an advantage
- B.Sc. degree in biological /chemical sciences, biomedical/mechanical engineering, or other related technical degree or equivalent experience in regulated industry.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?