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Quality Lab Tech - Medical Device
Location:
Bartlett, TN
Description:
Lincotek Medical is a global contract manufacturer providing full-service medical device development and manufacturing for the orthopedic market. With a focus on innovation and speed to market, Lincotek Medical is a unique company with the ability to guide OEMs through every step of the process, from ideation to high-volume production, providing true "Concept to Launch" support. We are looking for flexibility and commitment in the successful candidate and offer the following benefits: Benefits: Savings and Investment Plans / 401K + Company match Paid Time Off (PTO) Tuition Reimbursement Paid Holidays (10) Medical including Prescriptions and Vision Dental Short-Term and Long-term Disability Life & Accidental Death and Dismemberment 401K with company match Employee Assistance Program Flexible Spending Account Responsible for ensuring product meets the established standards of quality including reliability, usability and performance as required by the customer. Perform inspections, tests, and sampling of material used to produce plasma coated medical devices as well as on the coating itself while in compliance with all internal and regulatory standards Essential Functions 1. Follow LAB/SOP sampling procedures and directions for recording and reporting quality data 2. Review the implementation and efficiency of quality and inspection systems 3. Conduct testing and inspection of raw materials and products to ensure adequacy of finished product quality as required by the customer 4. Assist in the investigation of customer complaints and non-conformance issues 5. Collect samples for biological monitoring and interpret results 6. Maintain weekly records for cleanroom requirements 7. Assist in the planning and acceptance of validation activities 8. Use statistical software to determine process monitoring and validation requirements 9. Maintain up-to-date process monitoring charts 10. Perform XRD testing on powdered hydroxyapatite by following written SOPs 11. Perform tensile/shear testing 12. Perform stereological analysis on various coatings 13. Support production with up-to-date documentation regarding process monitoring information needed for the release of devices 14. Participate in material review boards (MRB) help develop and implement corrective actions to prevent non-conformances 15. Assist in the implementation of appropriate corrective actions as determined by the MRB 16. Assist in ongoing compliance with quality and industry regulatory requirements 17. Document product nonconformance as required 18. Maintain all controlled document files in a timely and accurate manner 19. Evaluate problems and make initial recommendations for possible corrective action to supervision 20. Work with Production Management and Quality Assurance to provide feedback to production operators 21. All other reasonable duties, as assigned Work Environment This job operates in both a lab and a manufacturing environment. The role routinely uses standard office equipment, such as computers, phones, photocopiers as well as mechanical and other testing equipment. The individual will be required to adhere to safety policies and procedures within the lab and on the manufacturing floor. Physical Demands While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, use hands to finger, handle or feel and reach with hands and arms. The employee is occasionally required to sit, climb or balance and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10lbs and occasionally lift and or move up to 50lbs. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Position Type/Expected Hours of Work This is a full-time position, Monday thru Friday 8:30 am to 5:30 pm, with additional hours as business needs necessitate. Required Education and Experience 1. High School Diploma or equivalent 2. Bachelor's Degree in Biology, Chemistry, or related science 3. Testing experience in accordance with ASTM standards preferred 4. Strong computer skills including Microsoft Office and statistical software Competencies 1. Attention to detail 2. Strong communication skills - verbal and written 3. Data collection, data management and analysis 4. Problem analysis and problem solving 5. Planning and organizing 6. Teamwork Job Posted by ApplicantPro
Company:
Lincotek Medical
Posted:
December 26 2023 on ApplicantPro
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More About this Listing: Quality Lab Tech - Medical Device
Quality Lab Tech - Medical Device is a Nurse & Healthcare Lab Technician Job at Lincotek Medical located in Bartlett TN. Find other listings like Quality Lab Tech - Medical Device by searching Oodle for Nurse & Healthcare Lab Technician Jobs.
Quality Lab Tech - Medical Device is a Nurse & Healthcare Lab Technician Job at Lincotek Medical located in Bartlett TN. Find other listings like Quality Lab Tech - Medical Device by searching Oodle for Nurse & Healthcare Lab Technician Jobs.