Philips Quality Project Leader m/f in Klagenfurt, Austria

Job purpose/aim:

The Quality Project Leader (QPL) is the integral owner of quality management process and ensures that development targets on product quality are achieved and that defined quality deliverables are available and quality processes are implemented and followed.

He/she provides leadership in steering all quality related activities in a development project.

The QPL is part of the project core team and participates in all consolidation meetings.

Responsible for all Oral Healthcare related quality activities. Coordination of Tasks and Reporting results to Quality Representative at Oral Health Care. Support the Process owner of the POHC Medical Process in KLU (Quality/ Product Development).

Your Responsibilities

You’re managing the QMS compliance of developed products. Business sells FDA Class I products. A major focus of this position will be working within a global network to communicate and address QMS topics.

Provide Leadership in steering quality management systems activities with ownership of Quality Management System Management Review and creation process, Corrective/Preventive Action System, and document control and training integration.

Ensure compliance to Philips Policies, ISO 9001, ISO 13485, 21 CFR 820, Canadian Food, Drugs, and Medical Devices Regulations (CMDR) and EU Medical Device Regulations.

Our Offer

Philips Personal Health business offers rich, new consumer experiences that meet consumers’ desire for wellness and pleasure throughout each part of their day and during key milestones throughout their life. We are a highly entrepreneurial organization, passionate about developing innovations that meet consumer’s personal health & well-being needs in a unique way, relative to their Mind, Body, and Appearance. The Personal Health Group is one of three market-driven sectors within Royal Philips Electronics that delivers lifestyle solutions aimed at improving the lives of 3 billion people a year by 2025. Named one of the Top 50 Happiest Companies in America, Philips provides a unique opportunity for each employee to create their legacy in life through their work in a way that is personally meaningful to them.

We Are Looking For

  • Working knowledge of GMP’s and other FDA regulations

  • Experience validating application activities.

  • Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.

  • Proven analytical capabilities

  • Excellent communication, organizational and project management skills

  • Successful experience working with cross functional teams across multiple work locations

  • Effective written and oral communications skills and computer skills required

  • Network oriented and able to interact with different business functions and can work within numerous systems

  • Work cooperatively in an international team environment Requirements:

  • Polytechnic degree (HTL) or Bachelor’s degree in a scientific or technical field

  • 3-7 years’ experience in product design and development related work experience with exposure to regulated products.

  • Ability to learn quickly and respond to changing priorities

  • Strong interpersonal communication skills as well as being a motivated team player

  • Good verbal and written communication skills, good team skills

  • Technical writing and presentation skills

  • Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project)

  • Ability to work with global Q&R organization

  • Vocational English in writing Desired/Preferred Qualifications

  • CRE / CQE Certification

  • Experience in medical device industry

  • Design for Lean Sigma (DFLS) / Six Sigma / Design for Reliability and Manufacturing (DRM) experience

  • Minitab experience

  • Strong statistics background

  • Experience with medical device regulations

In this role, you have the opportunity to ensure that development targets on product quality are achieved and defined quality deliverables are available. You provide leadership in steering all quality related activities in a development project and you part of the project core team.

You are responsible for

  • Managing the QMS compliance of developed products. Business sells FDA Class I products.

  • Working within a global network to communicate and address QMS topics.

  • Steering quality management systems activities with ownership of Quality Management System Management Review and creation process, Corrective/Preventive Action System, and document control and training integration

  • Ensuring compliance to Philips Policies, ISO 9001, ISO 13485, 21 CFR 820, Canadian Food, Drugs, and Medical Devices Regulations (CMDR) and EU Medical Device Regulations.

You are a part of the Oral Health Care Development Team Klagenfurt and responsible for all Oral Healthcare related quality activities.

To succeed in this role, you should have the following skills and experience

  • Polytechnic degree (HTL) or Bachelor’s degree in a scientific or technical field

  • 3-7 years’ experience in product design and development related work experience with exposure to regulated products.

  • Ability to learn quickly and respond to changing priorities

  • Strong interpersonal communication skills as well as being a motivated team player

  • Good verbal and written communication skills, good team skills

  • Technical writing and presentation skills

  • Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project)

  • Ability to work with global Q&R organization

  • Vocational English in writing

In return, we offer you attractive career opportunities in an international organization as well as various social benefits. You will be part of a passionate team and contribute to deliver innovation that matters.

The minimum yearly salary is equal to € 43.022.- / gross with willingness to overpay. The actual annual income is commensurate with the market, your qualifications, and experience.

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 the health 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 by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working 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 our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .