
Senior Quality Assurance Specialist
1 week ago
This role involves providing quality direction, governance, and best practices across the Quality Management System and supported programs.
The successful candidate will be responsible for ensuring regulatory and quality compliance throughout the product development lifecycle, including manufacturing, commercialization, and life-cycle management.
This position plays a critical part in ensuring product quality and patient safety through effective execution of quality processes.
Key Responsibilities- Lead project planning activities and develop comprehensive project plans, including scope, timelines, budget, resources, and project success criteria.
- Collaborate with cross-functional teams to coordinate project execution and ensure that project objectives and success criteria are met.
- Provide Quality direction to multiple concurrent product development programs to ensure product and process compliance with applicable regulatory and cGMP requirements.
- Author, review, and/or approve design history documentation and design manufacturing documentation.
- Strong working knowledge of quality systems of respective ISO norms.
- Strong project management skills.
- Proficient in computer system applications (SAP, master controls, etc) and communication skills.
- Manufacturing/Six Sigma Green Belt Certification or Black Belt Upon Hire preferred.
- Quality/Certified Quality Technician-ASQ (CQE or CQA) Upon Hire preferred.
- ISO 13485/15378/9001 Auditor or Lead Auditor Training / Certification Upon Hire preferred.
- Travel up to 26 business days per year.
- Sedentary physical requirements.
- Exhibit a strong 'quality first' mentality and ensure that product and process quality is held to the highest standard.
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