Quality Principal Engineer

Quality Principal Engineer Job Description

Quality Principal Engineer

In this role you

You will lead cross-functional initiatives and Projects, set quality engineering standards, and mentor the next generation of quality and technical engineers and leaders. This is a hands-on role with strategic impact on deep statistical and technical standardization and high-level architectural leadership.

• Represent the Quality function as a subject matter expert in Process verification- and validation activities from planning to execution, including Risk management on e.g. PFMEA and PMS activities
• Represent the Quality function as a subject matter expert in Incoming Inspection/Supplier Quality within a cross-functional team for new product development of medical devices.
• Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of components/material/products and production equipment.
• Develop strategy for the creation of test- and inspection plans for critical to Quality/Safety acceptance criteria with a risk-based approach related to Product/Part risk.
• Determine a global standard for Acceptance Quality Level (AQL) based on Product/Part criticality combined with a dynamic approach for incoming inspection test failures

• Bachelor's or Master's Degree in Quality Management, Supply Chain Management, Engineering, Operational excellence, Science or equivalent.
• 5+ years of experience as a Quality
  - Engineer in the medical device or IVD industry supporting the development of complex electro-mechanical devices is required or Master's with 3+ years
• Experience with manufacturing processes, shopfloor management, new product innovation and Project management are required.
• Working knowledge of QSR, CFR
  21
  
  Part
  820, MDD/EU-MDR, ISO-13485 and ISO-14971 is required. Experience in statistical and problem-solving techniques.
• Global experience working with multiple cultures and functions, experience in moderating heterogenous groups towards solutions.
• 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.

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 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.

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.

The pay range for this position in Murrysville PA is $110,000 to $155,000 Annually.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

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 Murrysville, PA.

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.