Sr. Manager, Quality

Vantive US Healthcare USA • Plymouth, MN

1d • Hybrid

About The Position

The Sr. Manager, Quality serves as the Quality Management Representative (QMR) for Vantive's Twin Cities R&D multi-site campus across three physical facilities. The role implements Vantive's Global Quality Management System and manages local QMS documentation, including procedures for Quality, R&D, Regulatory, and Facilities, with responsibility for compliance and product quality. The position also leads regulatory compliance and legal manufacturing quality responsibilities, supports continuous improvement, manages the Quality budget across multiple locations, and coaches and develops subordinates.

The position follows Vantive's flexible workplace policy, which requires a minimum of three days per week onsite. The estimated base salary is $144,000 to $198,000 annually, and the position may also be eligible for discretionary bonuses.

Requirements

• Bachelor of Science degree in Engineering or Science.
• At least 8 years of experience in Quality, Manufacturing, Engineering, or a related field.
• 3–4 years of supervisory experience.
• Knowledge of global regulatory and Quality requirements for the manufacture and marketing of medical devices.
• Knowledge of ISO 13485, FDA 21 CFR Parts 7, 11, 803, 806, 810, and 820, ISO 14971, MDD 93/42/EEC, and EU MDR 2017/745.
• Strong leadership skills and demonstrated success managing a large global team.
• Strong analytical and problem-solving skills.
• Strong verbal and written communication skills.
• Success working with multifunctional global teams and third-party development partners.
• Strong interpersonal, communication, influencing, and negotiation skills.
• Ability to analyze and solve complex problems through innovative thought and experience.

Responsibilities

• Serve as Quality lead for Person Responsible for Regulatory Compliance (PRRC) legal manufacturing responsibilities at Vantive Twin Cities sites, providing technical and strategic input for regulatory decisions aligned with business strategy.
• Manage Twin Cities sites' participation in the FDA Voluntary Improvement Program (VIP) through the Medical Device Discovery Appraisal Program (MDDAP), utilizing Capability Maturity Model Integration (CMMI).
• Oversee employee training and ensure multi-site personnel are qualified for their positions; train employees to serve as NCR/CAPA owners and Change Control (CCM) Record Owners, and administer Trackwise 8 system access.
• Identify, implement, and manage legal manufacturing quality responsibilities and procedures for products manufactured at other sites, including external manufacturers.
• Lead periodic management reviews to assess the suitability and effectiveness of the Quality Management System.
• Ensure conformance with regulations for QMS activities and legal manufacturing oversight.
• Arrange and host external regulatory inspections and audits, serving as the lead interface with regulators and auditors.
• Support other Vantive sites through on-site MDDAP appraisals as a CMMI Practitioner/Professional.
• Lead Non-conformance (NCR) and Corrective/Preventive Action (CAPA) processes for Twin Cities sites as subject matter expert and approver, ensuring compliance with QMS procedures.
• Lead periodic internal quality assessments or audits of site functions to analyze compliance and assess risk.
• Identify and manage continuous improvement projects aimed at improving quality, reliability, and cost.
• Develop a budget for a section or department and ensure adherence to the budget.
• Manage the Quality budget across multiple physical locations.
• Coach, train, and develop subordinates.

Benefits

• Medical, dental, and vision coverage starting on day one.
• Basic life, accident, short-term disability, long-term disability, and business travel accident insurance.
• Aon Pooled Employer Plan (Aon PEP) and Vantive 401(k) retirement savings plan.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays.
• Paid time off ranging from 20 to 35 days based on length of service.
• Family and medical leaves of absence.
• Paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.
• Potential eligibility for discretionary bonuses.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager