Senior Product Quality Engineer at Philips

Drachten, Frisia, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

01 Jul, 26

Salary

0.0

Posted On

02 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Regulatory Compliance, Risk Management, Stakeholder Management, Communication, Coaching, Product Standards, Verification, Validation, Continuous Improvement, Customer Centricity, Team Collaboration, Medical Device Regulations, Project Management, Problem Solving, Detail Orientation

Industry

Hospitals and Health Care

Description

Job Title Senior Product Quality Engineer Job Description Your role: Instruct, coach and facilitate project teams on the Quality Management System (procedures, policies, guidelines, tools and training). Coach project teams on relevant product standards and regulations (eg: IEC 60335, IEC 60601, 21 CFR 820, ISO 13485, ISO 9001). Drive and support quality & regulatory compliance to ensure products and services meet QMS requirements. Create and deliver quality function artifacts required by Grooming & Beauty for NPI projects, lifecycle management and post‑market surveillance. Review requirements management processes and outcomes to ensure traceability and completeness. Review product verification and validation plans, protocols and reports; ensure adequacy and alignment to risk and user needs. Ensure quality of risk management activities (UFMEA/DFMEA/PFMEA, HB‑SRA) and that risk controls are documented and verified. Ensure compliance to quality system requirements, regulations and standards within your area of responsibility. Coordinate timely communications, escalations and decision points across stakeholders. Balance compliance with speed: enable experimentation, deliberate trade‑offs and conscious risk ownership in early‑stage ventures. Participate in post‑market surveillance and CAPA activities where applicable, drive continuous improvement actions. Business acumen: ability to translate quality risks into business impact and options. Customer centric risk thinking: experience applying risk considerations during early customer validation and experiments, mindful of ethics and brand reputation. Team player: willingness to go beyond formal quality responsibilities in a small venture team to achieve outcomes. You're the right fit if: Bachelor’s degree or Master’s degree in Mechanical Engineering, Electronics Engineering, Science or equivalent. 5+ years of experience in the product quality management preferably in the medical device industry. Applied knowledge of global product and/or medical device regulations and standards (21 CFR Parts 803/806/820, ISO 13485, ISO 9001, IEC standards). Preferably experience in medical device industry. Proven ability to incorporate and manage stakeholder needs across the project lifecycle. Strong communicator — able to influence and align globally, across senior executives to operational teams; experience leading remote/virtual teams. Both detail‑oriented and able to see the big picture; pragmatic, decisive and outcomes focused. Comfortable with ambiguity and rapid change; able to make risk‑based trade‑offs to enable fast learning and iteration. Demonstrated ability to coach and embed quality practices in cross‑functional teams. How we work together We believe that we are better together than apart. For this role, this means working in-person at least 3 days per week. 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 the lives of others. • Learn more about our business. • Discover our rich and exciting history. • Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here. #LI-EU 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 100 countries 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. Know Your Rights

Responsibilities

Instruct and coach project teams on the Quality Management System and relevant product standards. Drive quality and regulatory compliance to ensure products meet QMS requirements and participate in post-market surveillance.