Senior Quality Manager - Medical Device

If you’re looking for a career with a company where you can make a difference, earn a competitive salary, and have ample professional growth opportunities, this is it.

TransMedics is a publicly traded, medical technology company revolutionizing what’s possible in organ transplant through innovation, collaboration, and commitment. We’re growing and transforming the transplantation industry through our Organ Care System (OCS™) technology platform & National OCS Program, preserving organs used in heart, lung, and liver patient transplants for safe transport nationwide.

With OCS Hubs in 16 states, we’re continuously striving to help make available more lifesaving organs for more patients by expanding our national reach across the United States. Currently we’re looking for talented, passionate people to help shape the future of our company and fulfill this critical mission in service of potential transplant recipients everywhere. We have an opening for a Senior Quality Manager at our corporate headquarters in the Andover, MA area. The Senior Quality Manager is responsible for developing quality assurance and leading the quality engineering team.

WE OFFER:
Competitive base salary
Medical, Dental, Vision Insurance
401K Plan with match
Employee Stock Purchase Plan (ESPP)
Flexible spending accounts
Life Insurance
Short- & long-term disability insurance
Pet Insurance
Paid vacation & holidays
Refer a friend and earn extra cash
Free Fitness Center (Andover, MA location)

RESPONSIBILITIES:

• Responsible for the application and maintenance of quality standards and the quality management system as they apply to products and services
• Responsible for internal audit process and supports 3rd party audits (ISO, FDA, etc.)
• Manages the Corrective and Preventive Action (CAPA) system
• Identifies product and process improvements; leads and supports their implementation
• Coordinate quality data collection, analyses and reporting for Management Reviews and Post Market Surveillance
• Lead and support initiatives to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate business growth
• Develops, maintains and improves quality processes to support Class III medical device, in according with 21CFR820, ISO 13485, MDSAP and MDR

REQUIREMENTS:

• Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations. Experience with MDR a plus.
• 8 years of proven experience in Quality in the medical device/biotechnology/pharmaceutical industry, or equivalent combination of education and experience; 5+ years experience managing Quality Assurance and/or Quality Engineering teams
• Experience with electronic QMS software system is a plus
• Highly detailed oriented with strong organization and prioritization skills
• Outstanding leadership skills and proven ability to attract, engage and retain team members
• BS in Engineering or technical discipline
• Must possess the ability to handle multiple projects and changing priorities

At TransMedics, we care about people—and that includes our employees. We know our employees are key to our success and the success of our patients. We offer an engaging, supportive work environment, great benefits, and the opportunity to shape both our future and the future of transplant medicine.

TransMedics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Job Type: Full-time

Pay: $86,318.62 - $103,953.60 per year

Benefits:

• Paid time off
• Life insurance
• Referral program
• Dental insurance
• Flexible spending account
• Health savings account
• Vision insurance
• 401(k) matching
• 401(k)
• Parental leave
• Health insurance

Supplemental pay types:

• Bonus pay

Application Question(s):

• Do you now or will you in the future need sponsorship?

Work Location: In person