Philips Engineer Quality Assurance Sr in Murrysville, Pennsylvania

Sr. Quality Assurance Engineer

You are responsible for

Outcomes: The successful candidate will:

  • Understand and apply FDA CFR 820, ISO 13485, ISO 14971, Canadian, Japanese, Brazilian and European medical device regulations.

  • Provide quality engineer support to ensure that products are manufactured with a high level of quality, while being in compliance with standards and regulations governing medical device manufacturing.

  • Administer and manage delivery holds and reconciliations for assigned product lines. Provide support for field actions as needed.

  • Develop, review and approve procedures, technical/validation reports, change notices, risk assessments, and other related quality system documentation.

  • Lead, support, or facilitate investigations, CAPAs, process changes, quality plans and other Quality activities.

  • Lead or support internal and external quality system audits. Drive resolution of nonconformities.

  • Manage quality engineering aspects of the transfer of new or existing products into the manufacturing facility.

  • Drive continuous improvement of products and processes to reduce the cost of non-quality (out-of-box failures, line yield, nonconforming material, and other available data).

  • Be team-oriented, communicate suggestions and concerns, generate solutions, be flexible, and provide positive interaction and feedback with peers and internal departments.

  • Occasional travel may be required.

Behaviors: The successful candidate will demonstrate:

  • Innovation & change - While ensuring quality, look for ways to enhance effectiveness and efficiency of the organization's systems, processes and tools. Eliminate bureaucracy. Be flexible to change what is not working well.

  • Communications - Giving and receiving information in a business-like, informative, understanding, and instructive manner, both written and verbally.

  • Collaboratation – Partner with manufacturing facility to inform, educate and problem solve in regards to QA processes

Growth: The successful candidate will:

  • Take accountability to execute their personal development plan to grow within current role and to prepare for future roles.

  • Continually be aware of or respond to FDA and ISO regulation changes to maintain manufacturing compliance.

You are part of

At Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve.

Skills and experience

Education:

  • BS in Electrical/Mechanical Engineering or science discipline

  • Preferred - ASQ Certified Quality Engineer or equivalent

Experience:

  • Minimum 5 years in medical device industry, demonstrated understanding of, and ability to interpret regulations and guidelines governing medical device development

  • Demonstrated understanding and experience in applying modern quality engineering and management concepts (statistical competency, acceptance sampling, DOE, control and capability studies, FMEA)

  • Demonstrated understanding and experience with process validation methodologies (IQ, OQ, PQ), willingness to work as a team player in a change oriented department

  • Experience interacting directly with suppliers, Manufacturing and Manufacturing support organizations preferred

  • Excellent technical writing, communication, and organizational skills required, experience with MS Office products required, experience with a statistical software package is a plus, ASQ Certified Quality Engineer is a plus

  • Excellent oral and written communication and interpersonal skills, ability to work independently and complete multiple assignments on time, required

Customer Focus, Action-Oriented, Team Building, Self-Development, Problem Solving, Ethics & Values. Time Management skills, especially in a multiple task environment, Conflict Management, Timely Decision Making, Listening and Self-Motivation are all requirements of this position.

We offer you

Here at Philips WE ARE Working Together for a Better Tomorrow

Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.

Why should you join Philips?

Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.

Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That’s okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA at http://www.twitter.com/PhilipsJobsNA .

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.

#LI-MR1

Sr. Quality Assurance Engineer

You are responsible for

Outcomes: The successful candidate will:

  • Understand and apply FDA CFR 820, ISO 13485, ISO 14971, Canadian, Japanese, Brazilian and European medical device regulations.

  • Provide quality engineer support to ensure that products are manufactured with a high level of quality, while being in compliance with standards and regulations governing medical device manufacturing.

  • Administer and manage delivery holds and reconciliations for assigned product lines. Provide support for field actions as needed.

  • Develop, review and approve procedures, technical/validation reports, change notices, risk assessments, and other related quality system documentation.

  • Lead, support, or facilitate investigations, CAPAs, process changes, quality plans and other Quality activities.

  • Lead or support internal and external quality system audits. Drive resolution of nonconformities.

  • Manage quality engineering aspects of the transfer of new or existing products into the manufacturing facility.

  • Drive continuous improvement of products and processes to reduce the cost of non-quality (out-of-box failures, line yield, nonconforming material, and other available data).

  • Be team-oriented, communicate suggestions and concerns, generate solutions, be flexible, and provide positive interaction and feedback with peers and internal departments.

  • Occasional travel may be required.

Behaviors: The successful candidate will demonstrate:

  • Innovation & change - While ensuring quality, look for ways to enhance effectiveness and efficiency of the organization's systems, processes and tools. Eliminate bureaucracy. Be flexible to change what is not working well.

  • Communications - Giving and receiving information in a business-like, informative, understanding, and instructive manner, both written and verbally.

  • Collaboratation – Partner with manufacturing facility to inform, educate and problem solve in regards to QA processes

Growth: The successful candidate will:

  • Take accountability to execute their personal development plan to grow within current role and to prepare for future roles.

  • Continually be aware of or respond to FDA and ISO regulation changes to maintain manufacturing compliance.

You are part of

At Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve.

Skills and experience

Education:

  • BS in Electrical/Mechanical Engineering or science discipline

  • Preferred - ASQ Certified Quality Engineer or equivalent

Experience:

  • Minimum 5 years in medical device industry, demonstrated understanding of, and ability to interpret regulations and guidelines governing medical device development

  • Demonstrated understanding and experience in applying modern quality engineering and management concepts (statistical competency, acceptance sampling, DOE, control and capability studies, FMEA)

  • Demonstrated understanding and experience with process validation methodologies (IQ, OQ, PQ), willingness to work as a team player in a change oriented department

  • Experience interacting directly with suppliers, Manufacturing and Manufacturing support organizations preferred

  • Excellent technical writing, communication, and organizational skills required, experience with MS Office products required, experience with a statistical software package is a plus, ASQ Certified Quality Engineer is a plus

  • Excellent oral and written communication and interpersonal skills, ability to work independently and complete multiple assignments on time, required

Customer Focus, Action-Oriented, Team Building, Self-Development, Problem Solving, Ethics & Values. Time Management skills, especially in a multiple task environment, Conflict Management, Timely Decision Making, Listening and Self-Motivation are all requirements of this position.

We offer you

Here at Philips WE ARE Working Together for a Better Tomorrow

Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.

Why should you join Philips?

Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.

Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That’s okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA at http://www.twitter.com/PhilipsJobsNA .

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.

#LI-MR1