Quality Engineer



Advert ID



Burr Oak,Constantine,St. Joseph,Elkhart,Centreville

Job Type




Salary Range

75000.0 - 85000.0 YEARLY

No. of Openings


Branch Information

Lansing, MI - Professional - (USA) 741 N Cedar St (Professional) MI Lansing , MI - 48901 Phone : 517-372-0888



Job Description


• Development and Management of Protocols with focus on new product validation & process qualification to establish a controlled process, ensuring reliable product – IQ, OQ, PQ
• Assist in the development and approval of new product launches
• Develop Control Plans
• Determine necessary acceptance activities to meet customer requirements
• Conduct and verify equipment calibration and maintenance protocols necessary for validations
• Trained employees to quality and compliance standards
• Supplier development
• Performed Risk Analysis and FMEA and initiated SPC to upgrade product and process success
• Directed new product validation & process qualification to establish controlled process, ensuring reliable product
• Implemented SPC strategy for production sampling and testing
• Develop procedures to standardize inspection and molding processes
• Facilitate and approve corrective actions
• Develops and initiates standards and methods for inspection, testing and evaluation.
• Devises sampling procedures, develops forms, creates instructions for recording, evaluating reports and reliability data.
• Develops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility.
• Respond to inquiries from users and technical support regarding functions and operations of software programs, measuring methods and tabulating data that relates to process, product reliability.
• Performs supervisory responsibilities as needed
• Other duties as assigned

Bachelor's degree (B. A.) from four-year college or university; or CQE, or Associate degree with two to four years related experience and/or training; or six to seven years of equivalent combination of education and experience.
Must have medical device manufacturing experience

Bachelors degree
2+ years as a Quality Engineer in manufacturing
Medical Device manufacturing experience required
Long term employment desired, no job hoppers please