Quality Engineering Manager
1 month ago
Quality Engineering Manager
Salt Lake City
About Us: Join our rapidly growing medical device design house and manufacturing facility, where innovation and dedication to high-quality products drive our success. Our energetic team is committed to exceeding customer and patient expectations through superior product quality and reliability.
Position Overview: We are seeking a Quality Engineering Manager to lead our team of skilled engineers in delivering top-notch medical devices. This role is pivotal in integrating quality throughout our manufacturing processes, ensuring our products consistently meet the highest standards. As a leader, you will foster a culture of continuous improvement, regulatory compliance, and customer satisfaction.
Key Responsibilities:
- Team Leadership: Lead, mentor, and develop a team of quality engineers, fostering a collaborative and high-performance environment focused on product excellence.
- Quality Integration: Embed quality assurance into manufacturing as a value-added function, performing root cause analysis, and driving data-based improvements.
- Regulatory Compliance: Ensure compliance with regulatory requirements and standards throughout the product lifecycle, from design and development to manufacturing.
- Design Control: Oversee design control processes and evaluate changes to design or manufacturing for their impact on device history files (DHF), ensuring any gaps are addressed.
- Risk Management: Lead product and process risk assessment activities, including hazard analysis and failure modes & effects analysis (DFMEA/PFMEA).
- Product Qualification: Manage product and process qualification activities, including complaint investigations, engineering studies, and statistical process control (SPC).
- Quality Methods: Develop and implement sampling, inspection, defect recognition, and product testing methods, utilizing statistical and quality engineering knowledge.
- Continuous Improvement: Promote continuous improvement through timely handling of investigations, risk assessments, deviations, non-conformance reports (NCRs), and corrective and preventive actions (CAPAs).
- Audit Support: Act as a subject matter expert during internal and external audits, providing expertise on device and Quality Management Systems (QMS).
Qualifications:
- Experience: Minimum 6 years in a quality engineering role within the medical device industry, including leadership experience.
- Leadership Skills: Proven ability to lead and develop a team, with strong interpersonal and communication skills.
- Technical Proficiency: Expertise in statistical techniques, design of experiments, and quality management software. Familiarity with 21 CFR 820, ISO 13485, ISO 14971, and FDA GMP practices.
- Regulatory Knowledge: In-depth understanding of medical device regulations and standards, with knowledge of MDSAP, EU MDD/MDR as a plus.
- Project Management: Ability to manage multiple projects and priorities in a fast-paced environment.
- Educational Background: Bachelor's degree in Engineering, Quality Management, or a related field. ASQ CQE certification preferred.
Why Join Us:
- Be part of a dynamic and innovative team at the forefront of medical device manufacturing.
- Lead impactful projects that enhance patient safety and product reliability.
- Enjoy opportunities for professional growth and development in a supportive environment.
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