In this role, you have the opportunity toProvide strategic and tactical direction to direct reports within the operations quality engineering and receiving inspection teams.
Key areas of responsibilities (KARS) for this role include:
- Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
- Provides guidance to subordinates within the latitude of established company policies.
- Formulates and recommends (changes to) policies and establishes procedures that affect the Business Group
- Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
- Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
- Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems and as an individual contributor and subject matter expert contributing to meet objectives.
- This position supports developing processes that will allow tracking effectiveness of design transfer of products into manufacturing and ongoing manufacturing operations quality performance. Tracking approaches including but not limited to first past yields in the mfg., Cost of Quality, Failure Investigation Root Cause analysis, Quality Nonconformance’s and other metrics. This positon will create tools that will enable the Q&R site team to drive process improvements and increases customer satisfaction.
- This position will also be responsible to lead in resolution of assigned Corrective and Preventative Actions (CAPA) including supporting other associates CAPA.
- In addition the candidate will team up manufacturing to sustain the products thought the full life cycle. Successful candidate will ensure compliance with the Quality System Regulations, 21 CFR Part 820, and ISO 13485. An associate in this position is viewed as an active and valued contributor to the process validation, and design transfer activities. The associate would be required to balance business objectives and quality requirements to determine readiness of projects to proceed to the next phase.
- Manages regulatory inspections, internal and external Audits, as assigned and questions relating to the operation of the Business sites in coordination with all other applicable company and manufacturing groups.
To succeed in this role, you should have the following skills and experience
- At least 5 years' experience as a Quality/Reliability Engineer or, Design or Manufacturing Engineer working within the framework of a Quality System. Experience with medical device manufacturing with electronic and/or electromechanical products required.
- Experience in FDA regulated Medical Device industry with design and manufacturing of Medical Device Products and relevant ISO-Standards like ISO 13485, 21 CFR Part 820, ISO 14971.
- At least 5 years' experience as a functional (people) manager.
- Demonstrated success in growing and coaching high performing engineering teams and leading change for product or process quality.
- Ability to lead, communicate, interact and influence effectively at technical and management levels across functions.
- Demonstrated a high level of continuous improvement philosophy
- Bachelor’s Degree in Engineering Discipline such as EE, ME, Industrial, Etc., or equivalent technical Degree; or equivalent combination of education and experience
- ASQ (CQE, CRE, CQA) Certifications a plus.
Why should you join Philips?Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across thehealth continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more bywatching this video.
To find out more about what it’s like working for Philips at a personal level, visit theWorking at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from ouremployee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about ourrecruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of thefrequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
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 contact888-367-7223, option 5, for assistance.