Quality Engineer

Harleysville, PA

Full Time

Experienced

Quality Engineer

Position Summary
The Quality Engineer is responsible for ensuring product quality, regulatory compliance, and continuous improvement within a fast-paced medical device manufacturing environment. This role partners with Engineering, Manufacturing, Operations, and Regulatory Affairs to maintain compliance with FDA and ISO requirements while supporting product development, process improvements, risk management, and quality system effectiveness throughout the product lifecycle.

This position provides an opportunity to make a direct impact on patient safety, product quality, and operational excellence.

Work Location & Employment Requirements

This is a fully onsite position and requires regular attendance at our manufacturing facility.
Relocation assistance is not available for this position.
Visa sponsorship is not available now or in the future.
Candidates must be legally authorized to work in the United States without current or future sponsorship requirements.

What You'll Be Doing:

Maintain and improve the Quality Management System (QMS) in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations.
Lead CAPA, NCR, root cause investigations, and corrective action activities.
Support validation activities, including IQ/OQ/PQ, test method validation, and software validation as applicable.
Develop and execute Gage R&R studies and inspection methodologies.
Perform risk management activities, including FMEA and hazard analyses.
Support internal, customer, supplier, and regulatory audits.
Collaborate with Engineering, Manufacturing, and Regulatory Affairs to ensure quality requirements are met throughout the product lifecycle.
Monitor quality metrics and drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
Support supplier quality activities, including supplier audits, evaluations, and incoming inspection processes.
Participate in design reviews and support design controls, DHR, DMR, and DHF documentation.
Support implementation and maintenance of electronic Quality Management Systems (eQMS).
Contribute to regulatory submissions, complaint investigations, and post-market quality activities.
Develop and deliver quality-related training as needed.

Required Qualifications

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
Minimum of 3-5 years of Quality Engineering experience in a regulated manufacturing environment.
Working knowledge of FDA 21 CFR Part 820 and/or ISO 13485 requirements.
Experience with CAPA, NCR, root cause analysis, risk management, and validation activities.
Experience supporting internal, customer, and regulatory audits.
Strong analytical, problem-solving, organizational, and communication skills.
Strong technical writing and documentation skills.
Proficiency with Microsoft Office applications.

Preferred Qualifications

Medical device industry experience.
Experience with EU MDR, MDSAP, and other international regulatory standards.
Knowledge of ISO 14971 and medical device risk management.
Experience with statistical software such as Minitab or JMP.
Experience with software validation and 21 CFR Part 11 compliance.
ASQ certifications (CQE, CQA, CBA) and/or Six Sigma Green Belt or Black Belt certification.
Experience with electronic Quality Management Systems (eQMS).
Ability to manage multiple projects and priorities in a regulated environment.

What We're Looking For:

The ideal candidate is a proactive, detail-oriented quality professional who enjoys solving complex problems, collaborating across functions, and driving continuous improvement. Success in this role requires strong technical expertise, sound judgement, and a commitment to maintaining the highest standards of product quality and regulatory compliance.

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Are you legally authorized to work in the United States without requiring current or future employer sponsorship?*

Will you now or in the future require visa sponsorship (including H-1B, TN, OPT, CPT, EAD sponsorship, or employment-based sponsorship) to work in the United States?*

This position is fully onsite and requires regular attendance at our manufacturing facility. Are you willing and able to work onsite full-time?*

Do you possess a Bachelor's degree or higher in Engineering, Quality, Life Sciences, or a related technical discipline?*

How many years of Quality Engineering experience do you have in a regulated manufacturing environment?*

Do you have experience working with FDA 21 CFR Part 820 and/or ISO 13485 quality system requirements?*

How many years of experience do you have in the medical device industry?*

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What types of audits have you supported?*

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Do you have direct experience with FDA 21 CFR Part 820 and ISO 13485?*

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Quality Engineer

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