Careers at Ameda
Our personal integrity, trust of our colleagues, and dedication to our work creates an environment of respect and excellence throughout Ameda®.
This Ameda Core Value leads to a team-oriented culture where all are challenged to think beyond the obvious. If you have a desire to learn, grow and innovate, you can find purpose and satisfaction with us. At Ameda, you can make a contribution to an industry dedicated to improving the lives of mothers and babies.
There is no typical day at Ameda. Our market and our customers are always changing. This results in a highly stimulating atmosphere, where each employee can flourish based on his or her area of expertise. Ameda is committed to creating opportunities for qualified, enthusiastic employees who want to broaden their skills. Our growth makes it possible to offer a spectrum of development options.
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).
The Ameda Medical Sales Specialist is responsible for creating a preference for Ameda Breastfeeding products and the company in the hospital acute care setting as well as other healthcare settings. Promote the sale of Ameda products and to provide education to clinicians. In addition, the Sales Specialist is responsible for maintaining Ameda ethical and professional selling standards. This position is remote, work from home, with a territory of Texas. The ideal location is Texas. Ameda’s headquarters is in Buffalo Grove IL.