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$28/hr–$35/hr
Full-time
high school, professional certificate
Medical Insurance, Health Reimbursement Account, Dental Insurance, Vision Insurance, Healthcare Flexible Spending Account, Dependent Care Flexible Spending Account
Posted 24d ago
~40 hrs/week
Responsibilities
Perform visual and dimensional inspections of raw goods and assemblies for Class III medical devices to ensure they meet quality standards. Responsibilities include reviewing supplier documentation, monitoring equipment calibration, and documenting non-conformances.
Requirements
Requires 1-3 years of quality control experience in medical device manufacturing and a high school diploma or equivalent. Candidates must be proficient in using inspection tools like calipers and have a strong understanding of CGMP and GDP.
Full job description
Job Description:
POSITION SUMMARY
This position involves ensuring products meet established quality standards and specifications at various points in the organization. Duties include inspection of critical components and other raw goods and assemblies used in Class III medical devices, examining shipments of raw goods and electronic components, and inspecting required traceability documentation. Key responsibilities include visual and dimensional inspection, performing tests to determine product functionality, maintaining records, and collaborating with various teams to improve quality.
This role is for a first shift position, with standard working hours from 7:00AM to 3:30PM.
RESPONSIBILITIES
This position is responsible for, but not limited to, the following:
Perform intermediate visual and dimensional inspection of product at in-process assembly and/or final inspection.
Interprets drawings, blueprints, and specifications to determine product acceptability. Approves products/batches by confirming specifications, and conducting visual and measurement tests.
Select proper AQL samples based on batch sizes, where required.
Record and reports inspection and testing data.
Review and interprets supplier documentation, including certificates of analysis or conformance, packing slips, sterilization reports, and other lot traceability documentation.
Monitor use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately.
Review products for re-work and confirms conformity to required quality specifications.
Conduct visual inspection under magnification for printed circuit board assemblies (PCBA), confirming conformity to specifications and IPC standards as required.
Ensure departmental compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, and safety (equipment, associate, and material).
Identify and documents non-conformances to specifications.
Conduct quality documents and lot traceability record review and release, including review of NCMR’s, deviations etc.
Perform other TransMedics tasks and duties as assigned/required.
MANAGEMENT RESPONSIBILITIES
This position manages the following positions on a daily basis.
This position will not have management responsibilities.
PHYSICAL ATTRIBUTES
Ability to lift up to 40 pounds
Ability to stand for long periods of time
Ability to use microscopes or other magnification devices for long periods of time
MINIMUM QUALIFICATIONS
1-3 years of Quality Control Experience in Medical Device Manufacturing Environments.
High School Diploma or equivalent job experience with additional training in the trade; or equivalent combination of education and experience
Understanding of CGMP and GDP required
Intermediate computer knowledge required. Working knowledge of Microsoft Word, and Outlook required.
Must be proficient in written and spoken English.
Ability to read, interpret, and understand drawings, blueprints, and specifications.
Must possess intermediate math skills: addition, subtraction, multiplication, division, and efficient use of a calculator.
Knowledge of inspection tools such as rulers and vernier calipers required. Other inspection tools such as Tappi Charts, micrometers, height gauges, thread gauges, and Vision System knowledge a plus.
PREFERRED QUALIFICATIONS
Excellent verbal and written communication skills.
Strong math skills including measuring dimensions using calibrated tools, and calculating specifications.
IPC-610 Certification
Knowledge of Microsoft Excel, Access, Powerpoint a plus.
Ability to work overtime hours, or support weekend operations a plus.
As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary.
Every Organ Wasted is a Life Not Saved.
TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.
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.
TransMedics is committed to equitable and transparent compensation. The expected hourly rate for this role is $28.20-$35.17, which represents the company’s current good-faith estimate of compensation for this position. Actual hour rate will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. Hourly roles may also be eligible for overtime, shift differentials, incentive programs, and our comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.
Employee Benefit:
Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
Dental
Vision
Healthcare Flexible Spending Account
Dependent Care Flexible Spending Account
Short Term Disability
Long Term Disability
401K Plan
Pet insurance
Employee Stock Purchase Plan
TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
Related keywords
Quality InspectorMedical DevicesClass III Medical DevicesIncoming InspectionCGMPGDPAQLIPC-610PCBAVernier CalipersMicrometersHeight GaugesThread GaugesVision SystemTappi ChartsNCMR
Redefining what's possible in organ transplantation
Industry
Medical Equipment Manufacturing
Company size
501-1,000 employees
Founded
1998
Headquarters
Andover, MA
LinkedIn followers
24,416
Total funding
$721M
Every Organ Wasted is a Life Not Saved.
TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, and clinical care.
With more than 25 years of commitment to excellence and innovation, TransMedics is at the forefront of advancing the field of organ transplantation. Our innovative Organ Care System (OCS™) technology is the only FDA-approved technology for lung, heart and liver transplant indications in the U.S., enabling the optimization and assessment of donor organs outside the human body and replacing a decades-old outdated standard of care: static cold storage (ice). Combined with our National OCS Program (NOP), a nationwide team of clinical experts, 24/7 logistics support, and the first-of-its-kind dedicated air & ground transport logistics network, we are enabling transplant centers to expand their search criteria for viable organ donors and grow overall transplant volumes in the U.S.
www.TransMedics.com
Offices: 200 Minuteman Road, Suite 302, Andover, MA 01810, US
Service IndustryHealth CareMedical DeviceWellnessMedical