Plymouth, MN, 55446, USA
4 days ago
Head of Quality Systems & Compliance, ISC Quality
**Head of Quality Systems & Compliance, ISC Quality** This leadership role is responsible for providing direction and execution regarding quality systems, compliance, and quality engineering services for the Integrated Supply Chain Quality Organization. **Your role:** + Drives the establishment and maintenance of the ISC quality management system, ensuring compliance with regulations and requirements globally where products are manufactured and marketed. + Lead strategic regulatory compliance team supporting ISC sites, ensuring full compliance of system and execution with regulations and standards such as 21 CFR Part 820, ISO 13485, and ISO 9001 for product manufacturing. Includes driving consistent inspection readiness activities, supporting external inspections and strategic oversight of observation responses and actions. + Lead Quality Engineering Center of Excellence, consisting of expertise and specialized skill sets related to production, process controls, and distribution. Driving ISC QA strategic initiatives such as acceptance activities, process monitoring, and nonconformance reductions to improve product quality, process effectiveness, and compliance. + Drive integrated supply chain quality planning and strategy. + Drive management responsibilities/reviews across the ISC manufacturing sites and regions, establishing KPIs and monitoring to ensure effectiveness of the Quality System and organization execution. + Acts as a key influence and change agent on the cross-functional leadership teams to effectively improve quality and compliance outcomes for ISC. + Lead, collaborate, and partner with site quality leaders, business unit quality, and global teams on strategic initiatives and transformations. + Attract, develop, and retain a team of high-skilled, quality, and compliance experts. Deploy talent development and succession planning. **You're the right fit if:** + Bachelor's / Master's Degree in Engineering, Business Administration, Quality Management or equivalent. + 11+ years of experience with Quality Management and Regulatory Compliance in the Medical Device/ Biotech industry or equivalent + Must have leadership experience in various aspects of Quality (including internal and external representation on Quality) AND preferably in at least one operating process domain, preferably supply chain + Must be experienced in establishing quality strategies, quality oversight and quality systems, preferably at the group/ corporate level in a large multinational company. + Must be familiar with business process management framework, including industry practices such as APQC. + Relevant training, experience, and certification in Continuous Improvement practices, such as Lean/ Six Sigma, are highly 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 apart. 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. + 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 $196,875 to $315,000 The pay range for this position in Cambridge, MA is $210,000 to $336,000 The pay range for this position in San Diego, CA is $210,000 to $336,000 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.   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. 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. **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. It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws. As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation 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. Equal Employment and Opportunity Employer/Disabled/Veteran
Confirmar seu email: Enviar Email