Senior Quality Assurance Engineer
Job TitleSenior Quality Assurance Engineer
Outcomes: The successful candidate will:
- Provide Quality Engineering support to Manufacturing, Engineering, Quality and Process Development teams to ensure that products are manufactured with a high level of quality, while being in compliance with regulations governing medical devices manufacturing.
- Provide guidance and help solve significant or chronic process or product problems. Discuss customer problems with Marketing, Sales and Customers as needed.
- Generate, analyze, and present reports on quality related Key Performance Indicators (KPI) such as line yields, final release, supplier performance and customer experiences to internal product improvement teams..
- Develop, review and approve procedures, technical / validation reports, change notices, and non-conforming material reports. Special emphasis on the simplification of processes and procedures.
- Support the implementation of quality improvement programs. Become proficient with SAP applications that track internal and external failures.
- Support Quality Systems such as delivery holds, internal and external audits, CAPA and investigations.
- May supervise other associates responsible for supporting the Quality effort.
Behaviors: The successful candidate will demonstrate:
- Team orientation with internal groups to achieve HRC business goals.
- Demonstrate good judgment and decision making.
- Action oriented to develop and implement practical solutions to solve technical problems.
- Demonstrate learning agility to embrace new methods and practices.
- Leadership that creates an environment that encourages individual contributions. Provides effective work direction for subordinates.
Growth: The successful candidate will:
- Be able to solve internal and external quality issues while maintaining focus on customer needs.
- Develop an expert understanding of regulations governing medical devices such as the QSR’s, ISO 9000, ISO 13485, CMDR and the MDD.
- Drive continuous improvement efforts with practical solutions. Simplify processes utilizing the least burdensome practices.
BS in Engineering required
- Minimum of 5 years experience working within the medical device industry. Demonstrated an understanding of, and ability to interpret, regulations and guidelines governing medical devices including QSR’s, ISO 9000, ISO 13485, CMDR and the MDD.
- Demonstrated understanding and experience in applying quality assurance and control tools (statistical analysis, DOE, gauge R&R and SPC).
- Strong working knowledge of process development and validation methodologies (IQ,OQ,PQ).
- Experience interacting directly with suppliers, Manufacturing, and Manufacturing support organizations.
- Demonstrated understanding and experience in applying quality engineering concepts such as process capability analysis, risk assessment, PFMEA and DFMEA.
This position is primarily a sedentary position which requires fine manipulation and simple grasping skills to operate standard office equipment. Must occasionally lift up to 10 pounds, and carry up to 25 pounds.
ABOUT THE ORGANIZATION:
Respironics, a worldwide leader of anticipating needs and providing valued solutions to the sleep and respiratory markets. The company’s focus is on home care, hospital, respiratory drug delivery and international markets providing programs that manage sleep disordered breathing, chronic obstructive pulmonary disease, asthma, infant care, congestive heart failure and restrictive lung disorders. Globally positioned has manufacturing facilities in several domestic and international markets.
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.
In case of difficulties with your job application please send an email to [email protected]
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