Ameda, Inc. is a leading producer of Class I and Class II medical devices supporting the retail and institutional Breastfeeding industry. We are currently seeking a Quality Manager to enhance our staff in Buffalo Grove, IL. The position reports to the Chief Operating Officer. We are looking for a supervisor looking to advance their career into a managerial role.
Ameda is looking for a Quality Manager responsible for developing, enhancing and maintaining quality assurance and design programs, policies, procedures and controls ensuring that the performance and quality of products conform to established standards and agency regulations. In addition, the Quality Manager will oversee the quality metrics with a focus on root cause investigations and prevention of problems and help achieve a culture of continuous improvement.
- Assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820, EU MDR, ISO 13485, etc.
- Main point of contact to prepare and submit appropriate documentation / communication to regulatory agencies.
- Central point for management of quality issues across the Global supplier base to identify and resolve quality related issues in product and process.
- Coordinate activities of quality contractors.
- Pro-actively identify and resolve quality trends and issues with Quality team to ensure products are manufactured in compliance with specifications.
- Manage and monitor the CAPA process to ensure quality issues are resolved and products are manufactured in compliance with written specifications.
- Oversee the quality system compliance by conducting internal audits, management review, quality meetings, and routine complaint trend analysis.
- Ensure processes needed for the quality management system are established, implemented, and maintained.
- Promote, educate and train personnel on quality system requirements, responsibility, and accountability.
- Coordination with team members to develop and maintain product specifications.
- Validate and verify requirements for new products and product changes are met.
- Contribute to defining strategic direction of the Quality Management System.
- Subject matter expert.
Required Technical Competencies:
- Bachelors Degree required
- 2+ years of supervisory skills or a supervisor looking to advance into a managerial role
- 2+ years medical device quality assurance experience is required as is a demonstrated knowledge and understanding of medical device regulatory requirements (Class 1 and 2 devices).
- Experience working with Global quality systems and Government regulatory requirements.
- Experience working with Global suppliers from Asia, Mexico, Europe & other international countries.
- Strong interpersonal skills and ability to work cross functionally across several product platforms.
- Effective technical writing skills.
- This position will interact extensively with regulatory agencies and must be able to effectively communicate company policies, procedures and processes.
- Working knowledge of problem solving techniques and statistics (e.g. Six Sigma methodology, 8d, 5s, etc...)
- CQE, CQA or other quality certification preferred
- Computer Skills (MS Office Suite).