Director, QA-Endovations - 16053

Job Description: General Summary: This senior leadership role in Quality Assurance requires the candidate to lead the oversight and integrity of all Quality for Boston Scientific devices for an assigned site or region. Develops, establishes and maintains 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 assembly, process and product functionality and develops disposition and corrective actions for recurring discrepancies. Submits appropriate metrics and reports to the company as part of the Management Review process.

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

Job Experience:
10+ Years of Design Experience of Complex Medical Instrumentation Products relating to laparoscopic, endoscopic, arthroscopic imaging, including hardware and software components


Duties and Responsibilities:
?Interface with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure compliance, determine responsibilities and solutions when required.
?Works directly with operating entities to ensure the conduct of inspections, statistical process control analyses and audits on a continuing basis as specified to enforce requirements and meet specifications.
?Establishes and ensures compliance with good housekeeping practices, employee hygiene and equipment sanitation; analyzes plant error, salvage, spoilage reports and process statistics for significant findings and conclusions; works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes
?May serve as the Management Representative for the designated business and associated site(s).
oMaintain compliance to Corporate Quality Management System
oManage and maintain effectiveness of Quality Management System
oRepresents the business or site to outside regulatory bodies
oEnsures submittal to the company a monthly report summarizing trend analysis on their defined and applicable quality system clauses and corresponding quality objectives via the Management Review System
oFacilitates the awareness of regulatory and customer requirements throughout the organization
?Develops and monitors department budgets
?Ensure implementation of functional excellence initiatives.
?Encourages problem-solving processes leading to leveragability of solutions across divisions
?Ensure sharing of initiatives/ideas and accomplishments across the divisions
?Responsible for succession planning and the development and implementation of retention strategies
?Proactively reviews future technologies and plans needed resources with appropriate technical skills through either external search or training to prepare.
?Coach, develop and mentor Quality employees. Allocates/re-allocates internal and external resources, as needed

Minimum Education & Experience:
Candidate possesses a B.S. Degree with a 10-14 years experience in quality and regulatory for medical devices and pharmaceuticals. 7-10 years of supervisory experience recommended. The majority of experience should be in medical devices. An advanced engineering degree or MBA is high

Searchable Keywords: Director, QA-Endovations - 16053 / 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.