About the role:
This leadership role in Quality Assurance requires the candidate to lead the oversight and integrity of Quality for Boston Scientific devices for assigned site or portion of a site. 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 assembly, process and product functionality and develops disposition and corrective actions for recurring discrepancies. Submits appropriate metrics and reports to the site quality management and/or to corporate as part of the Management Review process. The role may act as a liaison between the company and various governmental agencies and notified bodies 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
Your responsibilities include:
- Interface with assigned manufacturing, engineering, customer, vendor and subcontractor representatives to facilitate compliance, assists in determining responsibilities and solutions when required.
- Works directly with assigned entities to ensure the conduct of inspections, statistical process control analyses and audits are within guidelines.
- Reviews and monitors compliance with good housekeeping practices, employee hygiene and equipment sanitation; analyzes plant error, salvage, spoilage reports and process statistics for significant findings and conclusions; collaborates 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): maintain compliance to Corporate Quality Management System; manage and maintain effectiveness of Quality Management System; may represent the business or site to outside regulatory bodies; supports 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; facilitates the awareness of regulatory and customer requirements throughout the organization.
- 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.
What we’re looking for in you:
- BS in an engineering discipline with 3-5 years of technical experience OR MS/ME with 2-3 years of technical experience.
- 3-4 Years in Managerial experience
- Strong audit background, audit facing and audit facilitating
- Having knowledge of distribution, supply chain and logistics
- Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations; Ability to understand other medical device regulations and standards.
- Strong communication, presentation, facilitation, and project management skills.
- Proficiency with Microsoft Office suite.
- Applies continuous improvement principles in development of the quality system.
- Driven, energetic, self-assured professional with high personal integrity.
- Ability to develop effective, positive interpersonal relationships.
- ASQ CQE certification strongly
- Certified Green or Black Belt
- Experience in nonconforming material and CAPA methodologies/systems