Quality Manager I Job

Additional Locations: (n/a)

Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your life's work.

Quality Manager I

About the role:

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 to ensure lasting customer satisfaction. Reviews, analyzes and reports on quality discrepancies related to assembly, process and product function systems and develops disposition and corrective actions for recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to determine responsibilities and solutions. May serve as liaison between the company and the various governmental agencies. Works 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. 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.

Your responsibilities include:

• Assists in and/or manages functional deliverables and ensures technical excellence for product or technical development.
• Provides guidance and approval regarding quality strategies and approaches.
• Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff.
• Assists in and/or completes the development of budgets and monitors spending.
• Assists in identifying and developing department tools.
• Assists in and/or determines appropriate staff levels, schedules and resources. Works with project managers to understand priorities and plan resource and time allocation accordingly.
• Maintains and enhances cross-functional team relationships.
• Works cross-functionally in identifying and resolving technical issues.
• Monitors and evaluates project and department progress and results.

What we are looking for in you:

• BS in Mechanical, Electrical, Biomedical Engineering or related engineering degree
• Minimum of 8 years of Medical device engineering experience;
• Travel approximately 10-15% of the time
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366.
• Strong communication and presentation skills.
• Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).

Preferred Qualifications

• MS degree
• 10+ years of medical device engineering experience

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.

Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Requisition ID:475066