Sr. Manager, Quality

Vantive•Plymouth, MN

2d•$144,000 - $198,000•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 the Vantive Global Quality Management System and manages local QMS documents and procedures across Quality, R&D, Regulatory, Facilities, and other areas, with responsibility for compliance and product quality. The role is the Quality Lead for Person Responsible for Regulatory Compliance (PRRC) legal manufacturing responsibilities at the Twin Cities sites, provides technical and strategic input for regulatory decisions, and oversees quality and regulatory activities involving products manufactured at other sites and external manufacturers. It leads management reviews, regulatory inspections and audits, internal quality assessments, non-conformance and CAPA processes, and continuous improvement work. The position also supports other sites through MDDAP appraisals and manages training, personnel qualification, subordinate development, and the Quality budget across multiple locations.

Requirements

Bachelor of Science degree in Engineering or Science.
At least 8 years of experience in Quality, Manufacturing, Engineering, or a related field, including 3–4 years of supervisory experience.
Knowledge of global regulatory and quality requirements for the manufacture and marketing of medical devices, including 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 Management Representative for Vantive’s Twin Cities R&D multi-site campus across three physical facilities.
Implement the Vantive Global Quality Management System and manage local QMS documents and procedures for Quality, R&D, Regulatory, Facilities, and other functions.
Act as Quality Lead for Person Responsible for Regulatory Compliance (PRRC) legal manufacturing responsibilities for Vantive Twin Cities sites, providing technical and strategic input for regulatory decisions aligned with business strategy.
Manage the Twin Cities sites’ participation in the FDA Voluntary Improvement Program through the Medical Device Discovery Appraisal Program, utilizing Capability Maturity Model Integration.
Oversee employee training and ensure multi-site personnel are qualified for their positions; train employees to serve as NCR/CAPA owners, Change Control Record Owners, and Trackwise 8 system access site administrators.
Identify, implement, and manage legal manufacturing quality responsibilities and procedures for products manufactured at other sites, including external manufacturers.
Lead periodic management reviews to ensure the suitability and effectiveness of the QMS.
Ensure conformance with regulations concerning 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 or Professional.
Lead the Twin Cities sites’ non-conformance and corrective/preventive action processes 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 to improve quality, reliability, and cost.
Develop a budget for a section or department and ensure adherence to it.
Manage coaching, training, and development of subordinates.
Manage the Quality budget across multiple physical locations.

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 and Vantive 401(k) retirement savings plan, with investment options, financial education, and retirement resources.
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.
Childcare benefits.
The position may be eligible for discretionary bonuses.