In this role, you have the opportunity to
This position has responsibility to provide Quality Engineering support to the SRC 3PL locations, functional team lead responsibilities for Inspection, and provide back up support to Distribution and Postponement operations located in Mount Pleasant, PA, the UK, and Germany to ensure that products are warehoused, configured, and released with a high level of quality, while maintaining compliance with Quality System Regulations. In addition, this position will partner with other Philips quality systems that interface with the SRC QMS to ensure regulatory compliance and will be an active member of distribution/postponement projects to assure quality system compliance.
You are responsible for
Ensure compliance with Quality Management System, in accordance with Philips Policy, applicable world wide regulations and standards (FDA/ISO) Ensure Distribution and Postponement operations follow applicable company policies, procedures, standards, and regulations. Assist with internal and external audits as necessary. Respond to corrective actions in a timely manner and ensure that corrective actions are implemented and effective.
Review and approval of procedures, change notices, and other supporting distribution/postponement documentation. Review and approval of equipment (tooling files), process validation (MVPs and IQ/OQ/PQ protocols and reports), software validation, and process risk documentation to ensure compliance.
Provide technical guidance in support of process or product investigations.
Provide guidance and support to Distribution, Postponement, Inspection, and Operations teams in their day to day QA activities to include but not limited to: QN creation, disposition of non-conforming material, follow up and closure of the non-conforming material records to meet departmental targets, execution of delivery holds, QA Final Release, Inspection, investigations and other related projects. Review and approve QN’s in a timely manner to meet business needs.
Assist in the development and monitoring of QA metrics related to nonconforming material and other key measures and submit for QBRs/Management Review. Implement quality system process improvement initiatives to support the Distribution and Postponement operations. Identify, track, and plan for continuous improvement of the KPIs.
Participate with the rest of Philips Distribution and QA teams in creating, publicizing, and continuously improving the associated processes in the PQMS to ensure that the Distribution and Postponement functions are effective and efficient.
Facilitate and/or Participate on special projects as assigned by Manager.
Work with supplier quality on processes related to the acquisition of purchased services, solutions, materials, components, sub-assemblies, and completed products and to ensure vendor assessments are completed.
Functional Team Lead for Inspection at Mt. Pleasant PA and works with associates responsible for inspection at other locations to provide guidance and troubleshooting support – Acting as advisor to subordinates to meet schedules and/or solve technical problems. Develops and administers schedules, performance requirements.
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.
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.
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.
Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.
To succeed in this role, you should have the following skills and experience
BS in Engineering, Science Discipline, or equivalent required.
Minimum of 3 years of experience in medical device industry, demonstrated understanding of and ability to interpret regulations and guidelines governing medical devices, including CFRs, ISO 13485, EN 46001, and the MDD.
Demonstrated understanding and experience in applying modern quality assurance and control tools (statistical analysis , acceptance sampling, DOE , gauging and gauge R&R , Statistical Process Control, Process Validation, and Change Control ).
Demonstrated ability to manage/coordinate Investigations, CAPAs, Continuous Improvement projects, and LEAN efforts.
Excellent technical writing, communication, and organizational skills required.
Excellent oral and written communication and interpersonal skills, ability to work independently and complete multiple assignments on time, required.
Experience with MS Office products required.
Experience with SAP preferred.
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 .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.