Job Title
Director, Quality Management Systems & Compliance
Job Description
The Director of QMS & Compliance will provide strategic leadership to Enterprise Quality Management System (QMS) initiatives, drive audit/inspection readiness, and ensure high standards of quality and compliance in line with industry’s best practices.
Your role:
- Collaborates with senior leadership to influence and align quality strategy with business objectives, ensuring that quality management processes support operational efficiency, risk management, and strategic growth.
- Acts as a key advisor on quality-related risks and opportunities, providing expert guidance to executive leadership on regulatory changes, compliance risks, and quality trends to inform strategic decision-making.
- Develop, harmonize, consolidate and deploy standardized QMS frameworks, ensuring alignment with regulatory requirements and business needs.
- Proactively identify, prioritize, and lead projects aimed at improving quality compliance across all operational areas (Sites, CLS, etc.).
- Establish harmonized processes and risk assessments to pinpoint compliance gaps and standardize remediation projects.
- Assist in overseeing the internal and external audit planning and execution for all locations and functions, ensuring audit readiness and follow-up on findings.
- Manage relationships with Notified Bodies (NB) and support sites in regulatory discussions and changes.
- Ensure consistency, robustness, and standardization of MR content and reporting structures across sites
- Drive continuous improvement initiatives to enhance the structure and efficiency of Integrated Supply Chain (ISC) QMSs.
- Responsible for functional leadership of the QMS & Compliance Team, including succession planning and comprehensive talent management, driving employee selection, performance management, compensation management, and career development as well as planning, staffing, budgeting, managing priorities, and proposing/implementing methodological changes for a function/region/business.
- Facilitates cross-functional collaboration at a strategic level, working closely with other departments to address and resolve high-impact quality issues and ensure alignment with organizational quality objectives.
- Develops and maintains quality metrics and reports to track QMS performance, providing regular updates to management on quality performance and improvement initiatives.
You're the right fit if:
- You have a minimum of 10+ years’ experience in FDA regulated medical device environments, with extensive focus in QMS Compliance, as document control, internal audits, CAPA, and training programs, ensuring their effective implementation, compliance, and continuous improvement.
- You have a minimum of 5+ years’ experience in functional/strategic leadership of quality teams/organizations within global, matrixed organizations.
- You have robust understanding and deep knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR and other global medical device standards.
- You have detailed knowledge in Risk Management (ISO 14971), PFMEA, root cause analysis and design transfer activities.
- You have extensive experience leading/supporting regulatory inspections (FDA, Notified Bodies) including Front Room expertise
- You have extensive experience developing/maintaining quality metrics and reports to track QMS performance, providing regular updates to management on quality performance and improvement initiatives.
- You have a minimum of a Bachelor’s degree (Required) in Engineering, Life Sciences, or related technical field - Master’s degree preferred (MBA, MS, or equivalent)
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
How we work together:
We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.
About Philips:
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Philips Transparency Details:
- The pay range for this position in Plymouth, MN is $170,000 to $270,000
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
Additional Information:
- 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.
- May travel up to 15%
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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.