Quality Engineer Products and Systems

Job Description

Job title:
Quality Engineer, Products and Systems
Your role:

• Be part of Project team and participate in defining product design input, requirements, V&V, output and design transfer requirements and plans. Ensure product quality, compliance and state of art throughout the product lifecycle.
• Reaffirm that design input are transferred to product design and verified to confirm that design output meet the design input. In collaboration with multi-disciplinary team, lead the design for reliability to create a reliability plan and include the reliability requirements in product design.
• Ensure that reliability requirements are met through test, verification and validations, as applicable.
• A distinguished champion on patient safety and quality with expertise on quality and compliance principles like IEC60601, IEC 62304, IEC62366, 21CFR806. You will be acting as subject matter expert to provide guidance on product design quality, safety, reliability, serviceability, maintainability, manufacturability and other aspect in collaboration with business and technical SMEs.
• Well conversant with QMS requirements in accordance with ISO13485:2016 and ISO14971.
• Expert in medical device risk management principles including risk evaluation, assessment, risk determination, mitigation and risk benefit analysis. You will be acting as facilitator for risk management activities in accordance with ISO14971 and other applicable regulatory requirements.

You're the right fit if: (4 x bullets max)

• Experience: 12 to 20 Years, minimum 10 years in Medical device industry.
• Bachelor's in engineering or quality management, with 12 to 20 Years, minimum 10 years in Medical device industry.
• Proven knowledge of the FDA regulations for Design Controls for medical devices is a must and the combination with (extensive) experience with regulatory inspections has a very strong preference.
• Product Quality Engineering and Design Control experience is a requirement.
• Certification in Software Quality Engineering (CSQE) from ASQ or other bodies is desirable In-depth knowledge and a proven track record in implementing and applying concepts in the fields of designing in quality, reliability and problem-solving techniques have a strong preference. Leadership experience and good change management and influencing skills (required) You are Customer, Patient Safety and Quality focused. Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR. Advanced level knowledge of IEC62304, IEC62366 and ISO14971 has a strong preference.
• Excellent communication skills, able to clearly and concisely summarize complex technical problems You combine analytical and conceptual thinking, physical insight, system view, flexibility and a Handson mentality to deliver sustainable results and creative solutions. You are a motivated self-propelling person, with determination to succeed and the ability to manage change. Excellent organizational skills to lead and track deliverables Strong influencing skills power of persuasion, perseverance, getting things done mentality.

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 companyu2019s facilities.
Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations.

Indicate if this role is an office/field/onsite 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 the lives of others.
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If youu2019re 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 commitment to diversity and inclusion .