Quality Engineer

Quality Engineer Local Candidates Only - No Relocation Mid Level / NOT Sr.

Level Position Overview:

This position will support manufacturing quality operations in a dynamic, fast-paced, medical device manufacturing environment. This environment includes the manufacture, inspection, and test of devices for design verification, design validation, and commercial production.

Responsibilities:

Work cooperatively with other team members and in compliance with applicable standards and regulations such as 21 CFR 820 and

ISO 13485

2016 to transition products from development to manufacturing. Use experience within medical devices, to provide guidance and assistance in the development of new production processes Drive the development, implementation, and approval of PFMEAs and control plans. Develop inspection processes and sampling plans according to the risk level of the components, material and devices Facilitate the development, implementation, and approval of Device Master Records and Device History Records. Lead investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills. Develop and approve technical documents to plan work, such as Master Validation Plans, Quality Plans, and Qualification Protocols; support execution of work product. Collect and evaluate data, lead system and process improvements using six sigma tools Provide reliability and statistical analysis of data for investigations, qualifications, test method validations and other Quality related activities. Participate in

ISO 13485

audits and assist in FDA and other regulatory inspections

Qualifications and Skills:

3 + years of experience in occupation related to Quality Control of medical devices. Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and

ISO 13485

2016 is required. Experience participating in internal and external audits.

Education :

Bachelor's degree or equivalent experience in Industrial, Mechanical or related engineering / life sciences related discipline. #CNX200

Pay:

$60,000.00 - $90,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Retirement plan

Work Location:

In person