Quality & Regulatory Affairs Manager

Adecco Direct Placement is currently recruiting qualified candidates for a Quality Assurance and Regulatory Affairs Manager Job in Erie, PA for our client, a small but growing medical device manufacturer. The Quality Manager will assist with the compliance of the company’s Quality System and oversee the Regulatory Affairs compliance, customer issues, and post market activities associated with issue handling including Medical Device Regulatory submissions. The Quality Manager will report directly to the President and provide support and make recommendations to the President and senior staff for strategic planning purposes. Our client offers a base salary dependent on experience within the medical device manufacturing field and a comprehensive benefits package.

Responsibilities for the Quality and Regulatory Affairs Manager Job in Erie, PA include:
• Responsible for oversight and direct support of complaint handling procedures.
• Manage CAPA process, corrective actions, investigations.
• Participate in the development of corrective and preventative action plans and coordinate closure of actions with assigned responsible parties.
• Track and report on quality and measurements and metrics including complaints, in-process defects, field failures, and non-conforming materials.
• Analyze and prepare reports and data on Quality System effectiveness at management review meetings.
• Lead internal audits, as well as external customers’ and regulatory agencies’ audits, as required.
• Lead activities related to CE mark approval and ISO 13485 certification.
• Support compliance to Supplier Quality System – qualify, review, reassess and maintain supplier files; perform suppliers audits.
• Lead the Materials Review Board, and review/approve non-conforming material and related system documentation.
• Work closely with Operations to resolve internal and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-Proofing, etc.).
• Provide technical support for and final review and approval of customer complaint investigations.
Support new product development.
• Identify statistically-based sampling plans for inspections and validations.
• Facilitate the execution of Risk Management activities.
• Support validations for new and existing products, processes and equipment.
• Ensure compliance with cGMP, QSR, ISO 13485: 2016, MDR, MDSAP, and other applicable regulations/standards.
• Participate in FDA inspections, ISO Registration and surveillance audits and customer audits.
• Identify and implement opportunities for continuous improvement.
Interact and coordinate activities with other departments, external vendors and customers.
• Provide support necessary for supplier controls.

• Bachelor’s Degree in Engineering or Science is required
• Four (4) or more years of quality experience in a production environment, medical device/equipment preferred.
• Prior experience of 21 CFR Part 820, 93/42/Medical Device Regulations
• Knowledge of MDSAP, MDR and ISO 13485: 2016
• Experience with FDA submittals and Notified Body requirements
• Knowledge of Risk Management
• Ability to read blueprints and knowledge of calibration and testing methods
• Excellent verbal, written, presentation and interpersonal communication skills.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Ability to work successfully as part of a small team, with a willingness to jump in wherever needed.

If you meet the above qualifications and would like to apply for this position, please click APPLY NOW and upload your most current resume or you may email your resume to our recruiter, Madeleine Felion, at madeleine.felion@adeccona.com. Please include QA & RA Manager on the subject line of any e-mail correspondence. Questions regarding this position can be addressed by emailing or calling 814-844-6976. Thank you in advance for applying, however, only qualified candidates will be contacted.

The Adecco Group is a Fortune Global 500 company and the global leader in Human Resource Solutions. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your Professional Career. For great opportunities near you, go to www.adeccousa.com today!

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Reference number US_EN_2_226875_140916