Director, Process Compliance & Centers of Excellence

Philips International; Plymouth (MA); Sur place; USD 181 000 - 288 000; Plein temps

Avantages offerts par ce poste

Generous PTO

401k with match

HSA contribution

Stock purchase plan

Education reimbursement and more

Résumé du poste

Philips seeks a Director of Process Compliance & Centers of Excellence to lead enterprise quality controls, drive process improvements, and ensure regulatory alignment across R&D, manufacturing, and regulatory affairs.

You will develop PFMEA, design transfer activities, and mentor a high-performing team while partnering with Quality Optimization to integrate initiatives into site QMS.

Qualifications

• 10+ years of FDA regulated medical device experience with focus on QMS compliance, CAPA, Internal Audit and process improvement.
• 5+ years of strategic/functional leadership of quality teams in global matrixed organizations.
• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR and other medical device standards.
• Strong grounding in Risk Management (ISO 14971), PFMEA, root cause analysis and design transfer.
• Experience leading regulatory inspections (FDA, Notified Bodies) and CAPA/NC/QN programs.
• Bachelor’s degree required; Master’s degree preferred.

Responsabilités

• Spearhead strategic development and deployment of enterprise quality controls and process improvements.
• Lead organization-wide compliance initiatives and integrate new tools/processes into routines.
• Guide PFMEA assessment and design transfer activities with manufacturing and R& D.
• Mentor quality engineers and support NPI projects and product transfers.
• Drive cost reduction and productivity through COPQ data analysis and improvement initiatives.
• Oversee documentation for regulatory compliance and inspections.

Connaissances

FDA regulatory knowledge

QMS compliance

CAPA process

Internal Audit

Process improvement

Leadership

Regulatory inspections

PFMEA

Design transfer

Cost reduction (COPQ)

Formation

Bachelor's degree in Engineering/Life Sciences

Master’s degree (MBA/MS) preferred

Description du poste

Director, Process Compliance & Centers of Excellence

The Director, Process Compliance & Centers of Excellence is responsible for spearheading the strategic development and deployment of robust Enterprise quality controls and process improvements. They will lead organization-wide compliance initiatives, proactively drive integration of new tools & processes, and analyze data for trends and risks. Your role: Drives strategic initiatives to elevate supplier quality standards, collaborating closely with cross-functional teams in Research & Development (R&D), manufacturing, and regulatory affairs to address process gaps and maintain superior quality benchmarks. Guides setup of acceptance activities, including transfer to manufacturing resolve process deficiencies and develop New Product Introduction (NPI) validations, process development, process controls, inspection plans, and control plans. Collaborates with Quality Optimization team to integrate initiatives into site QMS processes. Analyzes data to identify trends, risks, and improvement opportunities and proactively support process improvement. Drive cost reduction and productivity through analysis of Cost of Poor Quality (COPQ) data and assist teams with implementation of cost saving initiatives Manages compliance with industry regulations and oversees the preparation and maintenance of documentation. Leads talent management, and succession planning and develops a high-performing team aligned with organizational goals. Authorizes the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities. Mentors and cultivate a culture of continuous learning and knowledge sharing among quality engineers, ensuring effective support for New Product Introduction (NPI) projects and seamless product transfers within the manufacturing facility. Possesses expert knowledge of products/services and advanced quality engineering techniques, recognized as expert within the field, and frequently interacts with senior management on matters around several functional areas. Works on complex issues, drawing on an in-depth understanding of the organization to analyze situations effectively, actively contributing to the development of organizational objectives and principles. Possesses broad cross-functional experience, demonstrates leadership exposure in a technical capacity, and is familiar with project management practices. Leads succession planning and comprehensive talent management, driving employee selection, performance management, compensation management, and career development in alignment with organizational operational goals.

Qualifications

• You have a minimum of 10+ years’ experience in FDA regulated medical device environments, with extensive focus in QMS Compliance, CAPA process, Internal Audit, and process/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)
• You have proven experience leading strategic process validation initiatives, CAPA processes, Non-Conformances (NC) and Quality Notifications (QN).
• 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.

Pay Range

The pay range for this position in Plymouth, MN is $170,000 to $270,000.

The pay range for this position in Latham, NY is $162,000 to $258,000.

The pay range for this position in Cambridge, MA is $181,000 to $288,000.

Benefits

• generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• stock purchase planeducation reimbursement
• and much more

Location and Travel

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-Based role.

You must reside in or within commuting distance to Plymouth, MN, Latham, NY or Cambridge,MA.

This role may require travel up to 25%

Company relocation benefits WILL NOT be provided for this position.

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.

Equal Employment Opportunity

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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