Are you a highly experienced and detail-oriented professional in the medical device industry? We are currently looking for a Senior Quality Assurance Manager (Med Device) in Indianapolis, IN to join a leading medical device company. This role offers an exciting opportunity to take ownership of quality management processes and lead initiatives that ensure compliance with industry regulations. If you have a passion for maintaining high standards and improving quality in a dynamic environment, this is the perfect opportunity for you.

About This Role

As the Senior Quality Assurance Manager (Med Device) in Indianapolis, IN, you will be responsible for overseeing quality systems, ensuring adherence to regulatory requirements, and maintaining high-quality standards throughout the product lifecycle. This role requires a deep understanding of industry regulations, such as ISO 13485 and FDA QSR, and a proven track record of leading cross-functional teams to drive continuous improvement. In this leadership position, you will play a pivotal role in developing and implementing quality assurance strategies that enhance product quality, minimize risks, and ensure customer satisfaction. You will collaborate with R&D, manufacturing, and operations teams to create processes that uphold the company’s commitment to quality and regulatory excellence.

Key Responsibilities – Senior Quality Assurance Manager (Med Device) in Indianapolis, IN

1. Lead and Manage Quality Systems

Oversee and ensure the implementation of the company’s quality management system (QMS).
Regularly audit and assess the quality system to ensure full compliance with regulatory standards.
Lead corrective and preventive action (CAPA) processes and ensure their timely completion.

2. Ensure Regulatory Compliance

Ensure adherence to FDA regulations and ISO 13485 standards for medical device manufacturing.
Lead internal and external audits and inspections, responding to findings and implementing corrective actions.
Stay updated on regulatory changes and communicate their impact on company processes.

3. Develop and Implement Quality Assurance Strategies

Collaborate with senior leadership to define and execute quality assurance strategies.
Analyze product quality data and trends to identify improvement opportunities.
Implement risk management strategies to mitigate potential quality issues.

4. Oversee Product Lifecycle Quality

Manage the quality of products from development through to manufacturing and post-market surveillance.
Review product design and development processes to ensure compliance with quality standards.
Conduct supplier evaluations and audits to ensure they meet quality and regulatory requirements.

5. Lead Cross-Functional Collaboration

Work closely with R&D, manufacturing, and regulatory teams to ensure quality standards are met.
Provide quality guidance on product design, development, and production processes.
Foster a collaborative environment that drives continuous improvement in product quality.

6. Monitor and Report Quality Metrics

Establish and track key quality performance indicators (KPIs) to measure product and process effectiveness.
Prepare and present quality reports to senior management, highlighting trends, risks, and improvements.
Continuously analyze performance data to identify areas for process optimization.

7. Develop and Deliver Training Programs

Provide training to staff on quality assurance principles, regulatory standards, and company procedures.
Conduct workshops and training sessions to promote a culture of quality within the organization.
Ensure that all team members are up-to-date on compliance and quality control requirements.

8. Drive Continuous Improvement Initiatives

Lead initiatives aimed at improving product quality, efficiency, and cost-effectiveness.
Use root cause analysis and problem-solving techniques to address quality challenges.
Ensure that improvements are sustainable and aligned with the company’s strategic goals.

This role offers a unique opportunity to make a direct impact on the quality of medical devices that improve patient outcomes, while working within a collaborative and innovative team environment.

What The Client is Looking For in You

To excel as the Senior Quality Assurance Manager (Med Device) in Indianapolis, IN, the ideal candidate will possess a combination of regulatory expertise, leadership capabilities, and a proven track record in medical device quality assurance. Specifically, the client is seeking someone who has:

Extensive Experience in Medical Device Quality Assurance – A deep understanding of FDA regulations, ISO 13485, and other relevant standards, with a history of successfully leading quality management systems in the medical device industry.
Strong Leadership Skills – Proven ability to lead cross-functional teams, mentor junior staff, and influence quality-related decisions at the senior management level.
Regulatory Expertise – Experience managing internal and external audits, ensuring compliance with quality standards, and staying current with changes in regulations.
Problem-Solving and Analytical Skills – Strong skills in identifying root causes of quality issues, proposing solutions, and implementing corrective and preventive actions.
Communication Skills – Ability to effectively communicate quality assurance results, issues, and improvements to both technical and non-technical stakeholders.
Experience with Product Lifecycle Management – Hands-on experience managing product quality through all stages of development, from design to post-market surveillance.

Why This Opportunity Stands Out

This position offers an exciting opportunity for an experienced Senior Quality Assurance Manager (Med Device) in Indianapolis, IN to play a critical role in shaping the future of medical device quality. Here’s why this opportunity stands out:

Impact on Healthcare – The chance to contribute to the development and delivery of high-quality medical devices that improve patient outcomes.
Leadership Role – Lead a talented quality assurance team, work closely with senior leadership, and have a direct impact on business strategy.
Career Growth – Join a company that values professional development and offers opportunities for advancement within the organization.
Dynamic Work Environment – Collaborate with R&D, manufacturing, and operations teams in a fast-paced and innovative setting.
Comprehensive Benefits – Enjoy a competitive salary, performance-based incentives, and a comprehensive benefits package, including health insurance, retirement plans, and more.

FAQs About the Role

Q: What industries should I have experience in?
A: You should have experience in the medical device industry, particularly in quality assurance, regulatory compliance, and product lifecycle management. Experience with FDA and ISO 13485 standards is essential.

Q: Is relocation required for this position?
A: The position is based in Indianapolis, IN. Candidates must either be local or open to relocation. A relocation package may be available for the right candidate.

Q: What is the reporting structure for this role?
A: The Senior Quality Assurance Manager (Med Device) in Indianapolis, IN, will report directly to the VP of Quality and work closely with cross-functional teams.

Q: What is the leadership style expected for this role?
A: The ideal candidate should have a hands-on, proactive leadership style, with the ability to motivate and guide a team, solve complex issues, and drive continuous improvement.

Q: Is travel required for this role?
A: Some travel may be required for supplier visits, audits, and industry conferences. However, most work will be based in Indianapolis, IN.

Q: What qualifications and skills are required for this role?
A: A bachelor’s degree in engineering, life sciences, or a related field is required. At least 5-7 years of experience in quality assurance within the medical device industry, including regulatory knowledge and team leadership, is essential.

Q: How does this role contribute to the company’s success?
A: The Senior Quality Assurance Manager (Med Device) in Indianapolis, IN, will ensure product quality and regulatory compliance, which are critical to the company’s success and growth in the competitive medical device market.

Q: What is the timeline for hiring and onboarding?
A: The company is looking to fill this role quickly, and the hiring process is expected to take 30–60 days. Onboarding will include training on company processes, quality systems, and product lines.

What Remuneration Can You Expect from This Job?

As the Senior Quality Assurance Manager (Med Device) in Indianapolis, IN, you can expect a highly competitive compensation package that reflects your experience and expertise in quality assurance within the medical device industry. The base salary for this position typically ranges between $90,000 and $120,000 per year, depending on your level of experience, certifications, and past achievements in managing quality assurance programs in regulated environments.

In addition to the base salary, you will be eligible for performance-based bonuses tied to the company’s quality performance, operational goals, and product success. Equity options or stock grants may also be available for the right candidate, allowing you to benefit from the company’s long-term growth.

The benefits package is comprehensive and includes healthcare coverage (medical, dental, and vision), 401(k) retirement plans with company matching, and other employee wellness programs. You will also receive paid time off (PTO), including vacation days, sick leave, and company holidays. Professional development opportunities will be offered to support continuous learning and career advancement within the company.

This is a unique opportunity to play a vital role in the growth of a leading medical device company while being rewarded with a competitive compensation package and excellent benefits.

How to Apply for This Senior Quality Assurance Manager (Med Device) Position in Indianapolis, IN

If you are an experienced quality assurance professional with a background in medical devices, we encourage you to apply for the Senior Quality Assurance Manager (Med Device) position in Indianapolis, IN. This is a fantastic opportunity to drive quality initiatives, ensure compliance, and make a direct impact on the success of a growing medical device company.

To apply, please submit your resume and cover letter, detailing your experience in quality assurance, regulatory compliance, and medical device manufacturing. Highlight your expertise in managing quality systems, audits, and ensuring adherence to industry standards.

This role offers an exciting opportunity to lead a dynamic quality assurance team and play a critical role in the company’s continued growth and success. Apply today to take the next step in your career!

For more information or to explore similar opportunities, visit our Medical Device Recruiters page.

Job Category: Senior Quality Assurance Manager

Job Type: Full Time

Job Location: Indianapolis

Senior Quality Assurance Manager (Med Device) in Indianapolis, IN