Quality Specialist

TransMedics•Andover, MA

About The Position

ESSENTIAL TASKS AND DUTIES INCLUDE: Review device history records for accuracy and regulatory compliance and compliance to TransMedics procedures. Review of paper and electronic records of components, sub-assemblies and final assemblies for conformance to specification. Review and release of sterilization loads, which includes, but not limited to the review of sterilization process data and biological indicator test results. Identify and report non-conformances of product, documentation or sterilization cycle. Complete product release activities of products post sterilization. Provide support to meet department and company objectives. Maintain compliance with all company policies and procedures (safety, regulatory, etc.). BACKGROUND AND QUALIFICATIONS: Experience working with team members to correct documentation non-conformances. Must be detail and quality oriented. Excellent interpersonal skills, excellent written and oral communication skills. Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude. Familiarity with FDA Code of Federal Regulations (21 CFR Part 210, 211 or 820 preferred) and ISO 13485 knowledge preferred. Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously. EDUCATION: Associates Degree and one year experience in DHR or batch record review or three years’ experience an FDA regulated environment.

Requirements

Experience working with team members to correct documentation non-conformances.
Must be detail and quality oriented.
Excellent interpersonal skills, excellent written and oral communication skills.
Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude.
Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously.
Associates Degree and one year experience in DHR or batch record review or three years’ experience an FDA regulated environment.

Nice To Haves

Familiarity with FDA Code of Federal Regulations (21 CFR Part 210, 211 or 820 preferred) and ISO 13485 knowledge preferred.

Responsibilities

Review device history records for accuracy and regulatory compliance and compliance to TransMedics procedures.
Review of paper and electronic records of components, sub-assemblies and final assemblies for conformance to specification.
Review and release of sterilization loads, which includes, but not limited to the review of sterilization process data and biological indicator test results.
Identify and report non-conformances of product, documentation or sterilization cycle.
Complete product release activities of products post sterilization.
Provide support to meet department and company objectives.
Maintain compliance with all company policies and procedures (safety, regulatory, etc.).