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.
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
- 5+ 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)
Required Behavioral Competencies
- Quality Orientation - Accomplishes tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checks processes and tasks; is watchful over a period of time.
- Builds Strategic Working Relationships - Develops and uses collaborative relationships to facilitate the accomplishment of work goals.
- Facilitates Change - Encourages others to seek opportunities for different and innovative approaches to addressing problems and opportunities; facilitating the implementation and acceptance of change within the workplace.
- Manages Work - Effectively manages one’s time and resources to ensure that work is completed efficiently.
- Decision Making – Identifies and understands issues, problems, and opportunities; compares data from different sources to draw conclusions; use effective approaches for choosing a course of action or developing appropriate solutions; take action that is consistent with available facts, constraints, and probable consequences.
- Initiates Action – Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive.
- Contributes to Team Success - Actively participates as a member of a team to move the team toward the completion of goals.