TransMedics
Manager Quality Control
Andover, MA
Sponsorship not specified$119k-$148kDetected 30 days ago
ExcelProcess ImprovementRecruitingControlsPatient CareFDA RegulatoryMedical DevicesCollaborationMentoringMicrosoft Office
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odds of building a lasting career here
33Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70
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About the role
- include managing and mentoring staff, analyzing data, and mitigating defects.
Responsibilities
- Supports technical aspects of the inspection process, including investigation of complaints.
- Supports manufacturing operations in product and new product development
- Support audits to demonstrate compliance of quality control systems
- Lead and support initiatives to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate business growth
- This position manages the following positions on a daily basis.
- This position has responsibility for Group Leads and Inspectors in various roles within the
Requirements
- At least 5 years' experience in managing direct reports in a Quality Control function
- Perform other TransMedics tasks and duties as required
Nice to have
- Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations.
- Experience with MDR a plus.
- Knowledge of statistical techniques.
- Proficient in MS Office Suite (i.e. Word, Excel, PowerPoint, Access).
- Must be team-oriented and collaborative
- Excellent interpersonal skills demonstrating the ability to work with others in a professional positive and collaborative manner
- Ability to work in a fast-paced environment and to meet tight deadlines
- Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
Skills
- Grasping, fine manipulation, feeling.
- Close vision, distance vision, color vision, peripheral vision, depth perception, ability to adjust focus.
- Ability to perceive sounds at normal speaking levels, including ability to hear and understand spoken instructions.
- Ability to perceive smells, tastes, or textures as relevant to the job.
- Exposure to hot or cold environments.
- Exposure to loud or distracting noises.
- Exposure to chemicals, machinery, or other potential dangers.
- Frequency and duration of repetitive movements.
- Mental/Emotional Demands:
- Stress levels, ability to handle change (tasks, workload).
- Ability to operate specific tools or machinery.
- Ability to work safely and follow safety procedures.
Compensation
- TransMedics is committed to equitable and transparent compensation.
Benefits
- Manage inspectors and inspection processes of medical devices. (1st shift)
- Vision: Close vision, distance vision, color vision, peripheral vision, depth perception, ability to adjust focus.
Company info
- Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant.
- Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do.
- Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.
Visa & Work Authorization
- Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships
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This listing is sourced directly from TransMedics's careers page and normalized into a canonical job model.