Overview
Quality Manager Jobs in Grand Haven, MI at The Pivot Group
At Viant, we partner and innovate with our customers to provide the highest quality, life-enhancing medical devices in the world.
The primary purpose of this role is to support Operations by ensuring adherence to Quality System requirements for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
Job Responsibilities:
Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
Monitor manufacturing of assigned products, ensuring compliance with DMR while providing deviation/waiver guidance and maintaining complete and correct Device History Records.
Implement various product and process improvement methodologies.
Review the adequacy and correctness of changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, etc. Maintain and update risk analyses as needed.
Complete protocols and reports for test method validation.
Interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommend process monitoring devices where applicable.
Develop various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval, and implementation of Incoming, In-Process, and Final Inspection procedures.
Ensure that the disposition of non-conforming materials meets all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
Effectively communicate and collaborate with customers and cross-functional teams.
Conduct complaint investigations.
Lead plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analysis.
Assist with product transfers.
Execute capability studies and apply statistical quality control methods, including Cpk, DOE, Hypotheses Testing, etc.
Coordinate the preparation of Quality Plans, including inspection, test, and gauge requirements for new product introductions.
Maintain strong communication skills and ability to work in a team environment.
Job Requirements:
Bachelor’s Degree in Engineering or related field (Preferred).
Knowledge and experience with standard inspection equipment (Calipers, micrometers, gauges, etc.).
0-2 years of experience in the Medical Device or other regulated industry (Automotive, Aerospace, Pharmaceutical).
Understanding of regulatory standards including FDA Quality Systems Regulation and ISO standards.
Experience with Gage Repeatability and Reproducibility (Gage R&R) studies (Preferred)
Benefits:
Medical, dental, and vision benefits effective from the date of hire.
Company-paid life insurance and disability benefits.
Generous paid time off and 10 paid holidays.
401k plan with company match.
Tuition reimbursement.
Voluntary Universal Life and Long-Term Care.
Voluntary Legal Plan.
Pet insurance.
Home ownership program.
Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.Show more
Title: Quality Manager
Company: The Pivot Group
Location: Grand Haven, MI
