Sr. Manager, Quality

Your Role

Quality Management Representative (QMR) for Vantive's Twin Cities R&D multi-site campus across three physical facilities. Implement the Vantive Global Quality Management System (QMS) and manage local QMS documents including procedures for Quality, R&D, Regulatory, Facilities, etc. for multiple Vantive Twin Cities sites, with responsibility for results in terms of compliance and product quality.

What You'll be Doing

• Quality Lead for Person Responsible for Regulatory Compliance (PRRC) for legal manufacturing responsibilities for Vantive Twin Cities sites; provide technical and strategic input for regulatory decisions aligned with business strategy.
• Manage Vantive Twin Cities sites' participation in the FDA's 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 position; train employees to be qualified NCR/CAPA owners, Change Control (CCM) Record Owners, and site administrator for Trackwise 8 system access.
• Identify, implement and manage the legal manufacturing quality responsibilities and procedures for products manufactured at other sites including external manufacturers.
• Lead periodic management reviews ensuring suitability and effectiveness of the Quality Management System (QMS).
• Understand and assure conformance to regulations with respect to QMS activities and legal manufacturing oversight.
• Arrange and host external regulatory inspections and audits acting as the lead interface with regulators and auditors.
• Support other Vantive sites via on-site appraisals through the MDDAP process as a CMMI Practitioner / Professional.
• Lead the Non-conformance (NCR) and Corrective/Preventive Action (CAPA) processes for the Vantive Twin Cities sites as both SME and Approver and ensure compliance with QMS procedures.
• Lead periodic internal quality assessments or audits of functions at the site to analyze compliance and assess risk.
• Identify and manage continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
• Develop budget for a section or department and ensure adherence to the budget.
• Manage the coaching, training and development of subordinates.
• Manage Quality budget across multiple physical locations.

What You'll Bring

• B.S. in Engineering or Science
• 8+ years' experience in Quality, Manufacturing, Engineering or related field which should include 3-4 years of supervisory experience
• Knowledge of the global Regulatory and Quality requirements for the manufacture and marketing of medical devices; knowledge of ISO 13485, FDA 21 CFR Part 7, 11, 803, 806, 810, 820, ISO 14971, MDD 93/42/EEC and EU MDR 2017/745
• Strong leadership skills and demonstrated success in 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/negotiation skills required
• Capable of analyzing and solving complex problems through innovative thought and experience