Compliance Manager II Endoscopy - 16389

Job Description: This leadership role in Quality Assurance requires the candidate to lead the oversight and integrity of Quality systems for Boston Scientific devices within assigned divisions. Represents division management quality systems and establishes appropriate standards and guidelines to ensure lasting customer satisfaction. Support the development and maintenance of quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines. Reviews, analyzes and reports on quality discrepancies related to divisional products manufactured by sites and works closely with manufacturing sites to develop disposition and corrective actions for recurring discrepancies. Works with divisional and site quality management to develop division management control requirements and facilitates all aspects of management review and divisional compliance requirements based on corporate requirements.

The role may act as a liaison between the company and various governmental agencies and notified bodies from around the world to foster compliance within BSC as required. Can be designated Quality Systems Management Representative in place of the VP's or Directors of Quality Assurance when required.

Duties and Responsibilities:
? Work directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
? Reports directly to Divisional QA Director and is responsible for facilitating the Divisional Management Review. Will ensure that all metrics presented to divisional management are in sync with sites and corporate. Will perform all the follow up work to set-up management review and closure of all action items.
? Will develop sound systems around management control and work closely with site QA to harmonize division management with management control requirements.
? Will be responsible of implementing new or revised corporate quality systems requirement within divisional groups and will facilitate need for appropriate training with human resources.
? Drives other quality projects of major magnitude and scope.
? Interface with R&D, Regulatory, manufacturing, engineering, customer, vendor and subcontractor representatives to determine responsibilities and solutions. Assists in the development and monitoring of department budgets
? Support implementation of functional excellence initiatives.
? Encourages problem-solving processes leading to leveragability of solutions across divisions
? Enable sharing of initiatives/ideas and accomplishments across the divisions
? Responsible for succession planning and the development and implementation of retention strategies
? Coach, develop and mentor Quality employees. Allocates/re-allocates internal and external resources, as needed with advice from Sr. Quality management.
? May be required to interface with Complaint Management Center to review complaint investigations and trend such complaints.
? As needed assist Divisional QA in managing quality engineering requirements with External Suppliers.

Job Experience:
Minimum Education & Experience:
Candidate possesses a B.S. Degree with a 8-12 years experience in quality and regulatory for medical devices and pharmaceuticals. 5-7 years of supervisory experience recommended. The majority of experience should be in medical devices. An advanced engineering degree or MBA is highly desirable.

Good grasp of FDA protocol and process.

Working Conditions:
General office environment, with potential (domestic and international) travel to BSC facilities for audits and other meetings

Competency Expectations:
? Demonstrated success in creating a strategies to lead a team to success
? Must be thoroughly familiar with the FDA and CE Marking and the Boston Scientific quality requirements associated with developing products in a regulated industry
? Broad understanding US and International regulations including 21 CFR, 820, 210, 211, and 11 is required.
? Excellent communication, facilitation and presentation skills (articulate and persuasive)
? Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with medical professionals
? Teaches and coaches others in technical and leadership areas.

Searchable Keywords: Compliance Manager II Endoscopy - 16389 / gj-mo

Minimum Education Required: Bachelor

Years of Experience Required: More than 5 years

Expected Travel Time: None

This company may offer relocation assistance.


Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.