Quality Engineer

Job Title: Quality Engineer

Location: Murrysville United States

time type: Full time

job requisition id: 583234

Job Description:

The Quality Engineer is responsible for resolving complex quality issues, utilizing post-market analytics for continuous improvement, and preparing for quality audits to maintain adherence to internal and external standards, working under general supervision. For example, this role includes preparing technical and standards-based information to respond to regulatory inquiries.

Your role:

• Addresses and resolves quality engineering issues of medium to high complexity, applying established processes and policies to provide efficient resolutions.
• Prepares for and support quality audits and inspections, ensuring all necessary documentation and processes are in place and compliant with internal and external standards.
• Reviews and assesses the detailed quality engineering documents, including quality plans for hardware, software, and system design, ensuring accuracy and regulatory compliance.
• Proposes and initiates multiple quality improvement projects, integrating quality, reliability, and Post Market Surveillance (PMS) plans at all stages of the product lifecycle.

You're the right fit if:

• You've acquired 1+ years of experience in medical device or a regulated industry, preferred.
• Your skills include proficiency in Root Cause Analysis, Risk Management, Correction and Removals, Auditing along with a general understanding of ISO 9001, ISO 13485, FDA CRF 21 part 820 and Good Manufacturing Practices (GMP). Must be proficient with Microsoft Office applications; experience with eQMS (Trackwise, ARIS) and ERP (SAP) software desired.
• You've acquired a Bachelor's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent/ Vocational Education.
• 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 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.

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.

Philips Transparency Details

The pay range for this position in Murrysville, PA is $63,000 to $88,200 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.

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 Murrysville, PA.

#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.