|Title:||Quality Assurance Manager|
|Job Location:||Grafton, WI|
Young Innovations is a manufacturer and marketer of high quality dental equipment and supplies. With an outstanding reputation for quality, our company has a broad portfolio of market leading products across a variety of categories.
We are seeking a talented, self-led, and energetic QA Manager to join our team at our Algonquin, IL location. The QA Manager ensures that the Quality and Regulatory standards are met or exceeded in all facets of the operation, and will also take a lead role in error cause removal and process improvement; and perform related duties as required.
- Manage and maintain compliance with FDA Quality System requirements which includes company registration, new product submissions, and management of CAPA system. Assist with the development of product submissions for FDA and other major market regulatory agencies.
- Complete all necessary regulatory work, including certification and validation necessary to pass governing regulatory agency standards, obtain certification marks for products, etc. Assist with maintenance of regulatory affairs product files to support compliance with regulatory requirements.
- Perform or take a lead role in internal/external auditing to ISO 13485 requirements, and ensure proper execution of supporting quality system throughout all facets of the operation including closing of findings. Lead and train the internal audit team to maintain compliance.
- Participate and be contact person during agency investigations, audits, and inspections. Prepare responses and corrective action reports.
- Provide support to market-released products to include review of labeling, promotional materials, product/manufacturing process changes and related quality system documentation changes.
- Ensure outstanding vendor performance via completion of vendor qualification, monitoring and measuring of supplier performance, and driving any appropriate action, including issuing and follow-up of CAPAs, and periodic completion of vendor review board.
- Perform investigations of non-conformances and product deviations, and conduct root cause investigation into NCRs leading to implementation of corrective actions.
- Evaluate field reports, complaints, product returns, and product analysis results to determine Medical Device Reporting (MDR) eligibility.
- Responsible for performing process validation and verification.
- Perform in-house calibration or administer outside calibration of measuring devices and equipment.
- Bachelor of Science degree in a related field.
- At least 7 years as a Quality Manager at a manufacturer and designer of Medical Devices.
- Experience participating and/or leading FDA audits or a similar combination of training and experience.
- In-depth knowledge of 21 CFR Part 820.
- Thorough knowledge of GMP’s.
- Experience with quality and regulatory programs and requirements.
- Knowledge of common manufacturing and distribution processes.
- Proficiency in MS Office Suite, and experience with ERP, WMS, and MRP software.
- Lean/Six Sigma knowledge and experience is preferred.
- Ability to prioritize, plan, perform and communicate activities both in written and verbal form.
- Ability to read and understand published regulations.
- Ability to present analysis and evaluation results in a cohesive, understandable and actionable format to cross-functional teams and decision-makers.
- Ability to communicate well at all levels of the organization.
- Ability to work effectively cross-functionally, influencing other key individuals outside of direct chain of command.
- Strong problem solving skills.
- Strong prioritization skills.
- Excellent leadership skills to include interpersonal, coaching, and facilitation skills.
- Excellent communication, analytical, negotiation, and organizational skills.
- A friendly, professional demeanor and ability to excel in a team-oriented environment.
- Strong attention-to-detail.
Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer