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Sr. Quality Manager

3 months ago

Salt Lake City, United States Sterling Engineering Inc. Full time
Job DescriptionJob DescriptionOverview:
As a Senior Quality Manager, you'll play a pivotal role in ensuring the highest standards of quality and compliance. You will lead a team of professionals, fostering a culture of excellence and driving continuous improvement. Your expertise will be instrumental in maintaining a robust Quality Management System (QMS) that meets regulatory requirements and exceeds customer expectations.

Job Responsibilities:
  • Manage and lead a team of Quality Engineers and Associates, providing guidance and mentorship in quality and medical device best practices.
  • Develop, maintain, and execute quality procedures to inspect and report quality issues, ensuring products meet specifications.
  • Oversee the maintenance and effectiveness of the ISO quality system, driving continuous improvement and compliance.
  • Lead internal and external audits, including CAPA, NCR, and customer complaints, ensuring thorough investigation, root cause analysis, and documentation.
  • Ensure document control, revision control, and process validation activities comply with regulatory requirements.
  • Collaborate with purchasing and co-manage the approved supplier list, evaluating suppliers for product compliance.
  • Foster a "culture of quality" by providing resources, support, and recommendations for growth.
  • Communicate effectively with management and stakeholders, upholding corporate values of safety, quality, ethics, and innovation.
Requirements:
  • Bachelor's degree in quality, risk management, mechanical or industrial engineering, or equivalent experience.
  • 8+ years of professional experience in quality management for medical device manufacturing, with progressive scope and responsibility.
  • Proven leadership and team management skills, with experience leading a diverse QA and QC team.
  • Certifications such as CQA, CQE, Lead Auditor, or Internal Auditor preferred.
  • Extensive knowledge of ISO 13485, 21 CFR 820, MDSAP, PPAP, Control Plans, PFMEA, GRR, and MSA.
  • Strong customer management, conflict resolution, project management, and decision-making abilities.
  • Excellent communication skills, both written and verbal, with a talent for presentations.
  • Experience in disposable products/cleanroom manufacturing is preferable.
  • Familiarity with REACH, RoHS, and Conflict Material Surveys is required.

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