In this role, you have the opportunity to
The Senior Manager of Quality Compliance underpins the overall quality culture within the Image Guided Therapy Devices business by teaming with professionals from other functions to move the business forward utilizing compliant, workable solutions. This role provides guidance to all levels of personnel within the organization, so the ideal candidate has a working knowledge of how to meet regulatory requirements in a practical, non-burdensome way, so they can advise on the best solutions for the business.
You are responsible for
- Providing guidance to end users on execution of QMS processes (e.g. Quality Planning, CAPA, NCR, Audit Finding resolution, Training, etc.). Ensures systems/processes are suitably designed and appropriate staffing is maintained to provide an effective quality system.
- Demonstrates effective change leadership
- Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
- Oversight of the Management Review, Internal Audit communications, Quality Planning, CAPA, NCR and Training programs. Ensures compliance to 21 CFR 11 and local processes.
- Select projects to support business needs and achieve departmental goals
- Providing compliance and QMS guidance across the business as needed. Primary areas include quality system changes, large-scale projects, day-to-day general questions.
- Leading larger scale training initiatives as it relates to any of the compliance/QMS processes within scope of position.
- Leading and developing succession plans for the Compliance/QMS Team, as applicable.
- Collaborating cross-functionally to drive overall improvement in the Compliance arena, as applicable.
- Meeting, and reporting on CAPA/Audit/Training/Quality Planning metrics as part of organizational goals and reporting requirements. Meeting forums include Management Review, CAPA Review Board meetings, Training or other quality meetings at the site level.
- Coordinating and taking part in external audits locally and as needed across the Business Group.
- Addressing non-compliance issues from both internal and external audits.
- Performing other duties as required.
To succeed in this role, you should have the following skills and experience
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- 10+ years of experience in quality assurance/operations/compliance in medical device industry preferred
- 5+ years of experience with Training and CAPA preferred
- 3+ years in a management or supervisory position preferably in quality function preferred
- Understanding of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO 14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169 and ISO 13485.
- Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships
- Multitasks, prioritizes and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
- Ability to leverage and/or engage others to accomplish projects
- Problem-solving and proficient computer skills are required
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously
- Must have demonstrated experience in leading others with a proactive attitude
- Experience with Windchill/ Trackwise/ CATSWeb is preferred
- ASQ (or other recognized Accreditation bodies, i.e. RAB/QSA/IRCA certification(s) ) preferred
- Ability to travel (up to 20%).