Sr. Quality Engineer
Position Summary
We are seeking a Senior Quality Engineer to support quality initiatives across product development, manufacturing, and post-market activities for a growing medical device organization. This individual will partner with cross-functional teams to ensure products consistently meet quality, regulatory, and customer requirements while driving continuous improvement efforts throughout the product lifecycle.
Key Responsibilities
- Provide quality engineering support for new and existing medical device products.
- Lead investigations related to product quality issues, nonconformances, and customer complaints.
- Support and drive Corrective and Preventive Action (CAPA) activities, including root cause analysis and effectiveness verification.
- Collaborate with Manufacturing, Supplier Quality, Regulatory Affairs, and R&D teams to resolve quality issues and implement sustainable solutions.
- Participate in risk management activities, including risk assessments and FMEA updates.
- Support design changes, process improvements, and product transfers through established quality system processes.
- Review and approve quality documentation, protocols, reports, and engineering changes.
- Analyze quality metrics and trends to identify opportunities for continuous improvement.
- Assist with internal and external audits, inspections, and regulatory compliance activities.
- Provide quality oversight for products that may include medical devices, combination device technologies, and associated manufacturing processes.
Qualifications
- Bachelor's degree in Engineering or related technical discipline.
- Several years of quality engineering experience within the medical device, life sciences, or regulated manufacturing industry.
- Working knowledge of quality systems, risk management, and problem-solving methodologies.
- Experience supporting cross-functional projects and driving quality improvements.
- Familiarity with FDA regulations, ISO standards, and industry best practices.
- Strong analytical, communication, and organizational skills.
Preferred Qualifications
- Experience supporting product development, manufacturing, or sustaining engineering activities.
- Knowledge of validation, verification, and statistical analysis methodologies.
- Experience participating in audits and regulatory inspections.
- Certification in Quality Engineering or related discipline is a plus.
What You'll Bring
- A proactive and collaborative approach to problem solving.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong technical judgment and attention to detail.
- Commitment to product quality, patient safety, and continuous improvement.
FAQs
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