Philips · 2 weeks ago
Senior Operations Quality Manager
Plymouth, MN
Full-time
Onsite
Senior Level, Lead/Staff
$120K/yr - $193K/yr
10+ years expPhilips is a health technology company dedicated to providing access to quality healthcare for everyone. They are seeking a Senior Operations Quality Manager to lead the Quality Operations team at their Plymouth, MN site, ensuring compliance with regulatory requirements and alignment with corporate goals.
B2BConsumer ElectronicsElectronicsLightingWellness
No H1B
Responsibilities
Responsible for functional team management including operations, budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, communicating job expectations, planning, coaching, training, and developing personal growth opportunities
Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to manufacturing operations within Philips or at contracted suppliers
Assists Change Control owners to assess impact of change, ensure compliance to change requirements, and approves change controls
Drives quality investigations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from nonconformances
Supports internal /external audit programs, assists in preparation of audit responses and leads CAPA activity-CAPA board, reviews investigations, ensures appropriate CAPA actions, may own CAPA
Manages- calibration activities for instrumentation, measurement and test equipment, resource optimization, and incoming material and outgoing product acceptance activities, resource optimization, and compliance with regulations
Identifies, facilitates, and/or leads continuous improvement efforts and maintains Quality Metrics to support process improvement activities
Responsible for coordinating, facilitating and follow up on any Quality Leadership Team action items assigned
Identifies and communicates risks and assists with risk mitigation plans as necessary and provides technical advice for partners and regulatory agency audits
Qualification
Required
Minimum of 10+ years' experience in FDA regulated medical device environments (drug-device combination products preferred), with a focus on Operations Quality (IQ/OQ/PQ), process/continuous improvement, CAPA activities, internal /external audit programs, receiving inspection, sterilization, calibration, chemical analysis, QMS/process/Testing standardization, training etc
Minimum of 3+ years' experience in functional team management including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc
Strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, cGMP, and GDP
Proven experience utilizing Quality KPI's/Data Analysis to assess team/site performance and identify process/continuous improvement opportunities
Proven ability to cultivate and maintain strong relationships with team members and internal/external stakeholders
Minimum of a Bachelor's degree in Quality, Engineering or a related Scientific discipline (required)
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position
This role may require travel up to 10%
US work authorization is a precondition of employment. The company WILL NOT consider candidates who require sponsorship for a work-authorized visa, now or in the future
Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Plymouth, MN
Preferred
ASQ certifications (desired)
Benefits
Generous PTO
401k (up to 7% match)
HSA (with company contribution)
Stock purchase plan
Education reimbursement
Company
Philips
Philips is a technology company that operates in various fields, including healthcare, consumer electronics, lighting, and home appliances.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$4.23BKey Investors
EXOR N.V.Bill & Melinda Gates FoundationInnovative Health Initiative
2025-03-19Post Ipo Equity
2024-05-23Post Ipo Debt· $756.82M
2023-11-07Grant· $44.6M
Leadership Team
Neil Mesher
CEO and SVP, UK and Ireland
Recent News
2026-01-22
2026-01-22
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