Sr Quality Manufacturing Engineer

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Company: Spectranetics

Location: Murrysville, PA 15668

Description:

Job Title
Sr Quality Manufacturing Engineer

Job Description

Sr. Quality Manufacturing Engineer

In this role you

Responsible for achieving a state of high quality performance, compliance and sustainability in product inspection and the factories while pursuing continuous quality improvement through the application of Quality Engineering practices.

Your role:

  • Product Ship Holds & Communications, Performs regulatory quality control supportive activities.
  • Defines and/or translates the product quality inspection Policy and Strategy within a domain into technical solutions.
  • Determines the product quality inspection approach within the project and executes those product quality inspection activities.
  • Non-Conformance events including CAPA management when required. Resolve quality non-conformities with Philips internal suppliers
  • Receiving Inspection / WIP inspection / FGD Release. Support SQE/SQA/Purchasing


You're the right fit if:

  • Bachelor's degree required. 5+ years of experience in a medical device or regulated industry (preferred).
  • Direct inspection engineering sustaining experience. Direct working relationship with suppliers
  • Knowledge of or exposure to quality systems, quality tools and methodologies, including Critical to Quality, FMEA, Root Cause Analysis , Pareto, 8-D, 5 Why, Audit training, skills, or willingness to learn; experience with auditing suppliers preferred.
  • Basic understanding of CAPA, as well as global medical device regulations, requirements and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.


How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.

This is an office role

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

  • Learn more about our business.
  • Discover our rich and exciting history.
  • Learn more about our purpose.
  • Learn more about our culture.


Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to San Diego, CA, Plymouth, MN, OR Colorado Springs, CO.

#LI-PHI

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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