In this role, you have the opportunity to
Execute as an Incoming Component Quality Engineer for the newly acquired Philips manufacturing facility in Minnesota. You will support site Business Units in development, transfer, installation and validation, beginning with a Class III combination device.
As an Incoming Component Quality Engineer, your responsibilities will be dynamic. You will lead a team of inspectors as they execute inspections as defined by our Standard Operating procedures, receiving inspection plans and Engineering drawings. You will also partner with the global Supplier Quality Engineering team to define, implement and validate new component inspection strategies. This position will support the full product quality life cycle. You will have the opportunity to work in a team environment to efficiently maintain quality standards and meet our customer demands.
You are responsible for
- Act as supervisor to QC inspectors (direct labor employees) ensuring First Article is performed on raw materials when applicable.
- Ensure team and own assigned training is accurate and complete
- Where required, execute inspections and accurately document results of inspection and testing following good documentation practices.
- Partner with Quality Engineering on the need for NCMR reports with quarantine of nonconforming materials, and/or participate in root cause investigations
- Manage quarantine inventory
- Partner with new project teams to manage development material inventory ensuring appropriate segregation from commercialize materials
- Own equipment and maintenance scheduled within the Receiving Inspection Lab and ensure equipment use are within calibration and preventive maintenance is completed before use.
- Lead in the construction and/or revision of SOPs for the inspection function. Complete required updates to SOP’s, Work Instructions, and Documents utilizing the Philips documentation system.
- Perform general housekeeping duties to provide an organized and safe working environment at all times.
- Develop and foster teamwork and positive working environment, while reducing work area distraction
- Ability to read, analyze and interpret engineering drawings, product specifications, receiving inspection plans, and test procedures.
- May perform visual, dimensional, and functional inspections on consumable products subassemblies, fixtures, and raw material
- May perform First Article Inspection on critical dimensions
- Understand and utilize Acceptance Sampling Plans using AQL sampling and 100% inspection.
- Knowledge and understanding of Geometric Dimensioning and Tolerancing (GD&T) and inspection techniques.
- Experience with typical QC inspection equipment including drop gages, rulers, calipers, video measuring system, microscope, micrometer, pin gages
- Execute training for QC inspectors, including use of various measuring equipment to collect data to determine acceptance
- Prepare area and may participate in internal and external quality audits.
- Must be flexible to support Receiving Inspection and/or QC inspections.
To succeed in this role, you should have the following skills and experience
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- Associates degree in technical field, engineering degree is preferred.
- 5 years of medical device experience in medical device or pharmaceutical industry. Quality Engineering or Supplier Quality Engineering background preferred.
- Proficiency with computers, including Microsoft Office, Material/Doc Control Software
- Excellent training abilities and skill
- Strong verbal and written communication skills.
- Ability to detect potential problems and recommend corrective actions.
- Extensive knowledge of Good Documentation Practices (GDP); able to provide coaching on GDP.
- Must be highly organized and detail oriented.
- Must be able to work with minimal supervision and independently takes on responsibilities.
- Experience with cleanroom or controlled environment room
- Experience with government regulated environment (e.g. FDA, FAA, ISO)
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. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without 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.
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