Design Quality Assurance Manager

Boston Scientific Gruppe; Arden Hills (MN); Hybrid; USD 99,000 - 189,000; Full time

Job summary

An established industry player is seeking a Design Quality Assurance Manager to lead a team in ensuring product quality and compliance in the medical device sector. This hybrid role emphasizes collaboration across departments, including R&D and Regulatory, to support new product development and sustain existing products. The ideal candidate will possess a strong background in Design Controls and Risk Management, along with supervisory experience. Join a forward-thinking company that values diversity and innovation, and play a crucial role in shaping the future of healthcare technology.

Qualifications

• 5+ years of relevant experience in Design Quality Assurance.
• Experience leading technical teams in the medical device industry.

Responsibilities

• Lead a team of Design Quality Assurance Engineers.
• Manage deliverables related to Design Controls and Risk Management.
• Foster a diverse and inclusive workplace.

Skills

Design Controls

Risk Management

Supervisory Skills

Problem-Solving

Team Leadership

Education

Bachelor’s Degree

Advanced Technical Degree

Tools

Windchill

Job description

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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we offer opportunities to work with diverse, high-performing teams on significant health industry challenges. We provide access to the latest tools, information, and training to support your career growth and ambitions.

About the role

Boston Scientific is recruiting a Design Quality Assurance (DQA) Manager at our Arden Hills, MN location. This role involves leading a team of engineers within the Pulse Field Ablation franchise to ensure product quality and compliance through Design Control and Risk Management processes. The position supports new product development and sustaining activities in electrophysiology products. It is a hybrid role, requiring on-site presence 4 days a week.

Your responsibilities will include:

1. Leading and developing a team of Design Quality Assurance Engineers supporting development and sustaining projects.
2. Fostering a diverse and inclusive workplace to maximize team contributions.
3. Managing deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance.
4. Providing technical guidance and working cross-functionally to resolve issues.
5. Building relationships with R&D, Process Development, Regulatory, Operations, and other departments.
6. Reviewing and approving documentation in Windchill.
7. Applying systematic problem-solving to quality and project issues.
8. Representing Quality to promote awareness and communication of quality initiatives across the organization.

What we're looking for in you:

Required qualifications:

• Bachelor’s degree and at least 5 years of relevant experience or equivalent
• Experience with Design Controls and Risk Management
• Ability to travel domestically and internationally
• At least 1 year of supervisory experience

Preferred qualifications:

• Advanced technical degree
• Experience leading technical teams
• Clinical experience
• Experience in the medical device industry
• Knowledge of ISO 13485, ISO 14971, 21 CFR 820

Additional information:

Requisition ID: 602374

Salary Range: $99,100 - $188,300

The compensation package varies based on location, experience, education, and organizational needs. It may include base salary, bonuses, and incentives as applicable.

Boston Scientific is committed to diversity and inclusion, ensuring equitable opportunities for all employees. We are an equal opportunity employer and comply with all applicable laws.

Note: Certain US positions may require proof of COVID-19 vaccination and drug testing for safety-sensitive roles.

Nearest Major Market: Minneapolis

Job Segment: QA, Quality Assurance, Risk Management, Compliance, Quality Manager, Technology, Quality, Finance, Legal