Reliability Quality Engineer (Emergency Care and Resuscitation)

Job TitleReliability Quality Engineer (Emergency Care and Resuscitation)

Job Description

Your challenge

Philips Healthcare’s Emergency Care and Resuscitation (ECR) business unit, manufacturer of Automated External Defibrillators (AEDs), is looking for a Quality Engineer, with specific responsibility for analyzing post market surveillance and manufacturing data to support product reliability initiatives.

Your team

Emergency Care and Resuscitation business unit

Our offer

As member of the Quality Engineering team, you will be expected to take a leadership role, with responsibility to work beside other parts of the AED organization to promote a quality culture and compliance to all regulatory requirements of a Class 3, PMA device. In addition, this role’s major focus will include statistical modeling of post market and manufacturing data to identify potential improvements in device or component design. This data analysis will support any necessary inputs into product safety risk management files and will fulfill risk benefit modeling requirements associated with health hazard evaluation and field action decisions. This role will partner with other members of the Quality team to ensure the quality system is compliant to internal Philips Quality System requirements and initiatives, as well as all applicable regulations and standards.

Team member of Post Market Analysis and Health Hazard Evaluation Teams

Development of data trending analysis from all QMS sources

Development of risk benefit analysis through appropriate statistical modeling methodology

Identify and team up to execute recommended quality improvements to support enhanced product and component reliability

We are looking for

This role requires expert knowledge of ISO 13485, FDA’s QSR, ISO 14971, the EU’s MDR and regulations governing medical devices shipped to Canada. In addition, diplomacy, flexibility and critical thinking will be required in working closely with all parts of the organization, to ensure the Quality Management System meets the current needs of the AED business and is sustainable. The ideal candidate is a self-motivated individual, who is excited by the prospect of working in a dynamic, fast-paced manufacturing environment.

Additional requirements include:

Bachelor’s Degree in science or engineering

Expert working knowledge of standards and regulations applicable the complete life cycle of a medical device

Requires strong working knowledge of quality assurance principles and practices, industry and international safety standards

Minimum of 8 years’ experience in manufacturing environments, within a quality assurance team, including collaboration with all manufacturing processes

Minimum 5 years in medical device environment

Must possess excellent communication (verbal & written) skills

Must practice analytical problem solving skills

Able to exercise judgment against the criteria of applicable regulations and standards

Proactive and able to act on own initiative

Excellent organizational skills to manage and track deliverables applicable focused areas of responsibility

Competent in the use of Microsoft Office programs

Experience in internal Quality System Auditing in accordance with ISO 19011; preference to CQA certification

Proven leadership ability with the experience of leading both directly and by influence, multi-functional teams.

Proven ability to work with mission and/or safety critical products in a highly regulated industry.

Proven ability to communicate in both verbal and written form to technical and non-technical customers, stakeholders, and various levels of management.

BS in a related technical field (EE, ME, Bio medical, Systems Engineering or Chemical Engineering). MS preferred.

Strong data analysis skills, including trending of field issues, product reliability and failure rate determination.

Experience with using statistical software such as Minitab, Weibull++, etc. to estimate and evaluate life distributions, time to failure data, warranty returns, etc.

Experience with quantitative risk assessment methods such as Fault Trees, Event Tees, Markov models.

Ability to understand and work well with various engineering functions and business functions (engineering, regulatory affairs, operations, marketing)

Strong documentation skills and attention to quality

Advanced degree in engineering, statistics, or data analysis

Experience with mathematical modelling and simulation, including Monte Carlo simulation, risk models

Knowledge of decision analysis methods and tools.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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.

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