Sr Quality Engineer
Position Overview:
As a Quality Engineer you will play a key role in ensuring that products and processes comply with regulatory and the companies standards. You’ll collaborate cross-functionally to drive continuous improvement, support manufacturing, and ensure the highest levels of product quality and patient safety. The role includes hands-on support in controlled environments, involvement with animal-origin tissue, and active participation in daily production activities.
• Provide quality engineering support for manufacturing, sustaining, and new product introduction.
• Participate in daily manufacturing tier meetings to support production and address quality-related concerns.
• Be present in controlled environment areas/clean rooms to monitor processes, support investigations, and ensure compliance with quality standards.
• Work with tissue from animal origin (porcine and bovine) in accordance with safety and regulatory requirements.
• Investigate product non-conformances and implement corrective and preventive actions (CAPA).
• Lead or participate in process validation activities (IQ/OQ/PQ).
• Ensure compliance with FDA QSR, ISO 13485, and other applicable regulations.
• Review and approve process and product changes.
• Analyze data, conduct risk assessments, and support root cause analysis.
• Lead or support internal and external audits.
• Participate in the development and review of quality documentation (procedures, protocols, reports). Minimum Requirements:
• Bachelor’s degree in Engineering, Science, or related technical field.
• 4+ years of experience in Quality Engineering or a related field in the medical device or regulated industry.
• Experience with Nonconformance material reports, CAPAs, and FMEA.
• Able to work with Bovine and Porcine tissue.
• Working knowledge of FDA regulations and ISO 13485. Preferred Qualifications:
• Experience with CAPA, risk management (FMEA), and process validation.
• ASQ certification (CQE, CQA) a plus.
• Strong communication and teamwork skills.
• Experience with statistical analysis and data interpretation. Pay ranges between 48-53/hr based on experience
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