Director, Quality Programs-Integrated Supply Chain (ISC)

Regulatory Jobs; Plymouth, Cambridge (MN, MA); On-site; USD 170,000 - 270,000; Full time

Benefits offered by this job

PTO

401k with match

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips in Plymouth, MN seeks a Director of Quality Programs-Integrated Supply Chain (ISC) to lead enterprise and site-level quality programs in FDA-regulated medical-device manufacturing. You will guide large-scale, global programs, manage a PMO/quality team, and ensure compliance with ISO 13485/14971 and 21 CFR standards.

You will oversee strategic planning, execution, and continuous improvement, leveraging data analytics to improve outcomes, reduce risk, and drive operational excellence; this

Qualifications

• Minimum 10+ years in FDA-regulated medical device manufacturing/supply chain with strategic leadership for global quality programs/projects.
• Proven program/project management experience in a matrix environment (PMO/Quality teams).
• Budgeting, workforce planning, performance management, employee engagement/retention, succession planning, coaching, training.
• Strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21 CFR 803, 806, 820, MDD/EU MDR, GMP, GDP.
• Proven expertise using/analyzing data analytics to assess program performance and drive improvements.
• Bachelor’s degree required; advanced degree or certifications preferred.

Responsibilities

• Lead, mentor, and manage a team of Program Managers and data analysts focused on quality programs.
• Foster a collaborative, high-performing culture across cross‑functional teams.
• Develop and execute strategic plans for quality programs, including AI initiatives, aligned with regulatory requirements.
• Oversee quality compliance projects within timelines and budgets; identify risks and mitigations.
• Ensure adherence to regulatory requirements and internal quality policies; monitor program effectiveness.
• Drive continuous improvement through data-driven initiatives and best practices.

Skills

Leadership

Team management

Cross-functional collaboration

Data analytics

Regulatory knowledge

Communication

Strategic thinking

Education

Bachelor’s degree in Quality, Engineering or related Scientific discipline

Advanced degree or certifications (Six Sigma, PMP) preferred

Job description

Job Title

Director, Quality Programs-Integrated Supply Chain (ISC)

Job Description

The Director, Quality Programs-Integrated Supply Chain (ISC) provides strategic leadership for enterprise and site-level quality programs within FDA regulated medical-device manufacturing environments. This role will lead large scale, global, cross-functional programs that strengthen the quality management system, improve compliance, reduce risk, and advance operational excellence.

Your role:

Leadership and Team Management:

• Lead, mentor, and manage a team of Program Managers and data analyst responsible for quality programs.
• Foster a collaborative and high-performance culture within the team.
• Provide guidance, support, and development opportunities to ensure team effectiveness and professional growth.

Strategic Planning and Execution:

• Develop and implement strategic plans for quality programs, including Artificial Intelligence (AI), that align with organizational goals and regulatory requirements.
• Oversee the planning, execution, and completion of quality compliance projects to ensure they lead them in accordance with timelines, budgets, and objectives.
• Identify and address potential risks and issues that could impact project success.

Product Quality, Quality Management System, Compliance and Standards:

• Ensure adherence to industry standards, regulatory requirements, and internal quality policies.
• Monitor and evaluate the effectiveness of quality programs, making adjustments as needed to maintain compliance and improve outcomes.
• Stay informed about industry trends and best practices to continuously enhance quality programs.
• Lead improvements in data and analytics by improvement current tools and practices

Cross-Functional Collaboration:

• Collaborate with other departments, including Operations Quality, Operations, Engineering, Business , and Supply Chain, on programs and outcomes.
• Serve as the primary point of contact for quality-related inquiries and concerns from internal stakeholders.

Reporting and Documentation:

• Prepare and present reports on project status, performance metrics, and compliance to senior management.
• Ensure accurate and timely documentation of quality program activities, including project plans, reports, and compliance records.

Continuous Improvement:

• Drive a culture of continuous improvement by implementing best practices and innovative solutions to enhance quality and efficiency.
• Lead initiatives to identify opportunities for process improvements and implement corrective actions as needed

You're the right fit if:

• You have a minimum of 10+ years’ experience in FDA regulated medical device manufacturing/supply chain environments, providing strategic leadership for large scale, global, cross-functional quality programs/projects.
• You have a proven track record of successful program/project management, transformation, change management, continuous improvement and team leadership in a matrix environment
• You have proven experience in functional management of PMO/Quality teams, including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
• You have strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, GMP, and GDP.
• You have proven expertise utilizing/improving data analytics- Quality KPI’s/Data Analysis to assess program/quality/team performance and identify process and continuous improvement opportunities.
• You’re able to effectively communicate, influence and build relationships with cross-functional team members at ALL levels.
• You have a minimum of a Bachelor’s degree in Quality, Engineering or a related Scientific discipline (required). Advanced degree or relevant certifications (e.g., Six Sigma, PMP) preferred.
• 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 of healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

• The pay range for this position in Plymouth, MN is $170,000 to $270,000
• The pay range for this position in Cambridge, MA is $181,000 to $288,000

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.

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.

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 or Cambridge, MA.
• This role may require travel up to 25%.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.