Buffalo Filter LLC
Lancaster, NY

Posted Friday, March 02, 2018

Job Description:

It’s a great time to join the team at Buffalo Filter, LLC. We have an immediate opening for a Senior Quality & Regulatory Affairs Specialist.

Buffalo Filter is a world leading medical device manufacturer and supplier of surgical smoke evacuation equipment. Our products are used to evacuate and filter hazardous smoke plume and/or aerosols created during over 95% of all surgical procedures.

Summary: The role of the Senior Quality and Regulatory Specialist is to support new product development for OEM products in both a quality and regulatory capacity to ensure products meet customer requirements and maintain state of the art. This position will be responsible to interface directly with customers to provide a high level of quality and regulatory support that meets or exceeds customer expectations.

Duties & Responsibilities:
1. Perform duties required for supporting OEM customers including: audit hosting, contract review, new product development support, resolving complaint issues with customers and regulatory authorities, assuming responsibility for regulatory compliance for OEM medical devices sold to the European Union and product registration support for other countries.
2. Review and comply with all applicable quality system regulations and company policies and procedures.
3. Perform Clinical Evaluations and prepare Clinical Evaluation Reports according to current standards and requirements for OEM products.
4. Investigate and document customer complaints using 8D problem solving tools as appropriate.
5. Compile periodic reports for review of customer complaints and use the data to revise the product risk documentation.
6. Prepare and submit change requests to OEM customers for product and process changes as required by the customer.
7. Participate on new product development teams for OEM products. Provide Quality and Regulatory support including: preparing Technical File documentation, US 510(k) documentation, and validation reports as needed.
8. For any assigned CAPAs, coordinate containment and correction activities, perform root cause investigation, develop corrective action plan and evaluate effectiveness.
9. Assist OEM customers with product registration requirements in Canada by completing private label licence applications.
10. Perform and document Internal Audits as assigned.
11. Participate in external audits from customers and Regulatory Bodies.
12. Review labeling requirements for OEM products registering them in the FDA GUDID database.
13. Recommend improvements to the quality system based on review of new regulations to maintain compliance to state of the art requirements.
14. Participate on the Environmental Team to support the EMS

Education & Qualifications:
1. BS in biomedical engineering/technical field required.
2. 10-15 years relevant experience in quality and/or regulatory in FDA regulated industry.
3. Ability to read and interpret engineering drawings, regulations, and other technical documents.
4. Knowledge of medical device manufacturing processes and requirements
5. Team leadership and/or supervisory skills to work closely within department
6. Excellent communication, organizational and multi-tasking skills.

Reply to this Posting with resume.

Buffalo Filter is an equal opportunity employer and makes employment decisions without regard to race, gender identity, sexual orientation, disability, or protected veteran status.

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