Sr. Quality Manager/Quality Manager - United States
- Responsible for overseeing post market surveillance, adverse events and recalls for Diagnostics.
- Manage and oversee global initiatives as they impact the Diagnostics organization.
- This person is responsible for communicating with the FDA for recalls, MDRs, periodic updates, etc..
- They will also be responsible for coordinating with the sites and IT to ensure that projects are appropriately prioritized, resourced and held to schedule. Additionally, the role will be responsible for Quality oversight of regional offices
- This position reports to the Director, Quality and Compliance for Diagnostics.
DUTIES AND RESPONSIBILITIES / ESSENTIAL FUNCTIONS:
Partner with Diagnostics Senior Management and local Site Management to facilitate post market surveillance across manufacturing sites. Partner with cross functional team members to drive quality improvement activities and lean principles within the organization.
- Serve as the Diagnostics expert on post market surveillance activities, ensuring sites are supported through the decision making activity, closure, and termination of issues.
- Assist in establishing robust and consistent evaluation methodology ensuring reporting of adverse events are consistently applied across all Dx sites.
- Function as the Subject Matter Expert on post market surveillance matters.
- Drive continuous improvement and LEAN activities with the sites to improve efficiencies in post market activities.
- Function as the Dx champion for IT projects impacting the Quality function and/or systems.
- Oversee the Akron Quality team ensuring that all feedback mechanisms are captured and addressed in a timely maner.
- Provide quality support for the Dx service organization and partner with local sites for improvement activities.
- Manage regional quality managers in Mexico and APAC to suppor the Dx business.
- Oversee quality activities related to R&D as well as CCMS.
- Ownership responsibility for the Dx business level QMR, establishing and disseminating metrics applied across all sites.
Other Training: Continuous improvement experience preferred (6 Sigma, Lean, Green Belt/Black Belt)
- Minimum of 5 years managing Quality Assurance in the Medical Device Industry and 10 years working in the Medical Device Industry.
- Experience and knowledge of medical device software a plus.
- Extensive knowledge of ISO 13485, FDA CFR 820, and emerging standards and regulations.
- Excellent team building and leadership skills that motivate team members to drive projects to a successful conclusion; must be able to manage and lead without direct authority.
- Excellent judgment skills in order to provide strong guidance and counsel to the site and line staff.
- Time management skills for oneself and of others on a team, ability to drive projects to scheduled completion.
- Strong data analysis skills.
- Superior interpersonal, verbal and written communication skills.
- Exceptional organizational, negotiation, and problem solving skills.
- Ability to work in a matrixed organizational structure, developing strong relationships with all levels of management.
Office conditions with 20-30% travel required.
Sitting, standing, walking, climbing stairs
WORK HOURS AND SHIFT (If applicable)
8:00am – 5:00pm Monday through Friday with additional hours as required to complete the duties of the position.
Quality Assurance Managers