Mistras Group
Quality Engineer - validations, procedures, FDA, ISO-13485, medical devices
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NDT.org Job Number: 22161 * Please reference NDT.org Job Number on all correspondence
Contact: Tom Medvec
Fax: 330-722-7360
Company: Medvec Resources Group
State: FL Florida
Contact: Tom Medvec
Country: United States
Pay: up to $85,000 year
Quality Engineer – validations, procedures, FDA, ISO-13485, medical devices

MANUFACTURING WITH A FUTURE!!!

Growing medical orthopedic manufacturer is expanding their Florida operation. We are searching for Quality Engineers with direct medical device experience and Bachelors degree, preferably in engineering or science.

Knowledge of ISO13485, FDA, GMP and IQ, OQ, PQ protocols is required. The Quality Engineer is responsible for writing protocols, conducting validations of special processes, review and approval of validations at suppliers and assisting suppliers with developing protocols of special processes. Experience planning, directing and developing quality standards for various processes, materials and products. The Quality Engineer develops and initiates standards and methods for inspection, testing and evaluation. Past experience developing sampling procedures, developing documentation forms and instructions for recoding, evaluating both quality and reliability data is a must. The Quality Engineer will establish programs to evaluate the accuracy of production, testing and measuring equipment, as well as, development of methods and procedures for disposition of discrepant materials. Experience developing training material and conducting training sessions involving methods, procedures and quality requirements is also required.

Our client offers a state of the art work environment, tuition reimbursement, possible career advancement and the stability of a growing company. They provide health, dental, vision, life, short/long term disability insurances, generally 401(K) match, annual bonuses and a excellent vacation program, starting with 3 weeks the first year. Our client pays the expenses for interviewing and provides a relocation assistance program. Enjoy warm weather and beaches year round in a great area for families. This is one of the best times to move to Florida in 30 years.

MUST HAVE: a Bachelors degree preferably in Engineering or science and a minimum of 3 years in Quality Engineering or quality Control. Experience in a medical manufacturing environment producing metal and/or plastic devices is a huge plus.

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Keywords related to position include: FDA, GMP, ISO-13485, ISO 13485, ISO13485, validation, IQ.OQ.PQ, IQ, OQ, PQ, clean room, passivation, class I, class II, class III, medical devices, medical device, orthopedics, orthopedic, implants, implant, joint replacement, surgical, surgical instruments, trauma, bone screw, bone screws, medical machining, spinal implant, surgical implant, surgical implants, medical implant, medical implants, orthopaedic surgical products, orthopaedic surgery products, shoulder implants, knee implants, hip implants, small joint implants, arthroscopic surgery products, arthroscopic surgical products
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