Manufacturing Quality Engineer will oversee the Quality Assurance in the processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses.

The processes include the introduction/validation of new/changed manufacturing processes and their associated quality systems, the trend analysis and monitoring of manufacturing processes and their environment, the remediation to non-conformances, and the development and improvement of quality systems.

Your role:

• Ensuring that appropriate quality plans are made and a suitable quality system is in place, for both NPI’s as well as for ongoing manufacturing that include all stages of the manufacture of the product/system and supports Quality System design

• Validating risk analyses and risk mitigation plans and activities, control plans, and Quality Systems.

• Overseeing processes: trend analysis, assess impact and follow-up (e.g., in QS updates, control plans, competency upgrades, etc.)

• Reviewing calibration plans and records, environmental controls, and training plans and records

• Organizing IQA audits, and execute internal audits for regulated products to assess the effectiveness of the QMS linked to production controls

• Approving which processes need validation/re-validation

You're the right fit if:

• You’ve acquired 5+ years of engineering experience in the related field or a combination of equivalent education and relevant experience

• Your skills include Proficiency in the use of various measuring tools and troubleshooting equipment

• You have a Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, Process Engineering or related technical discipline, preferred.

• You have solid experience in Risk Management for medical devices ISO 14971 and regulated industry experience

• You have Knowledge of statistical analysis (Minitab)

• You’re an excellent communicator and have people skills to engage with diverse stakeholders, including leadership team, project teams, vendors, and regulatory agencies

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

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.

• Read more about our employee benefits.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

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.

For this position, you must reside in or within commuting distance to Reedsville , PA .

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It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

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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