Document Control Coordinator - Quality Assurance

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 Document Control Coordinator to support our corporate headquarters in the Andover, MA area.

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:

• Maintain confidentiality regarding sensitive documentation
• Assist Document Control Manager with Document Control PLM system in support of other departments
• Maintain all Quality Records from inception to archival as hard files/electronic files
• Assist in training and maintain training with company training process
• Internal reporting for various company system metrics
• Ensure easy and efficient retrieval of documents internally and externally
• Assist in updating device regulatory labels in label software
• Issue controlled Laboratory Notebooks to cross functional departments
• Update and maintain Standards Database
• Assist with Quality Audits
• Maintain continuity of digital files to ensure naming standards, appropriate file locations, format standardization
• Scanning of Quality Documentation

REQUIREMENTS:

• Documentation Management Database experience preferred
• Attention to detail with exceptional proof reading and quality control skills
• Strong organizational skills with the ability to work with a high degree of accuracy
• Familiarity with a Quality Management System or other regulated environment
• Excellent interpersonal, verbal, and written communication skills. Ability to communicate effectively with all members of the company
• Proficient with Microsoft office software
• 3-5 years’ experience working in a regulated industry; Quality Control experience strongly preferred
• High School Diploma

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: $24.35 - $29.33 per hour

Benefits:

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

Supplemental pay types:

• Bonus pay

Application Question(s):

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

Work Location: In person