Philips · 2 weeks ago
Senior Quality Lead-Quality Compliance
Cambridge, MA
Full-time
Onsite
Mid, Senior Level
$120K/yr - $193K/yr
7+ years expPhilips is a health technology company focused on improving healthcare access for everyone. The Senior Quality Lead-Quality Compliance will act as a Subject Matter Expert for non-conformance and will drive process validation maturity while overseeing global Quality and Regulatory requirements.
B2BConsumer ElectronicsElectronicsLightingWellness
No H1B
U.S. Citizen Only
Responsibilities
Implement and provide oversight of consistent global Quality and Regulatory requirements related to elements supporting the overall operations and process controls
Ensures that appropriate standards and processes are in place for new product introduction, as well as for ongoing manufacturing that includes all stages of the manufacture of the product/system
Oversee the Quality Assurance activities in the processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and /or procedures for regulated products /businesses
Have an impact on processes such as the introduction/validation of new/changed manufacturing processes and their associated Quality systems, trend analysis and monitoring of manufacturing processes and their environment, remediation to non-conformances, and the development and improvement of Quality systems
Serve as best practice/quality resource within your own discipline or as technical expert on functional or cross-functional teams/projects. You also act on a global scale across all Philips businesses and factories
Qualification
Required
Minimum of 7+ years' experience in quality engineering within FDA regulated medical device manufacturing environments
Full understanding of manufacturing operations
Proven expertise in non-conformance, driving non-conformance reduction and process validation
Ability to utilize creative problem-solving techniques in resolving a wide range of issues
Relentless focus on Product Quality and Patient Safety
Demonstrated leadership skills and ability to influence change
Strong knowledge of principles, theories, and concepts relevant to Quality Engineering (CQE body of knowledge)
Detailed knowledge of appropriate global medical device regulations, requirements and standards including 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282)
Strong knowledge of Risk Management (ISO 14971, FMEA), Acceptance activities, Non-Conformance, Production and Process Controls, and Process Validation activities
Minimum of a Bachelor's Degree in Quality, Engineering or related field (Mathematics, Statistics, etc.)
Lean Six Sigma Black Belt or Master Black Belt certified
Excellent communicator with strong negotiation and relationship management skills
Strong ability to make data-driven decisions and move teams through vague and complex situations
Ability to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation
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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