Quality Assurance Engineer

Micron Products, Inc.

Innovative manufacturer of plastic injection molded and precision machined metal components for medical, defense,
and commercial markets seeks energetic quality assurance engineer to join our team.

Candidates must have 3-5 years of experience in a quality assurance or related position. Candidates also must have a background with DOE, FMEA, ISO 13485, CAPA, and validation protocols.

Key Functions:

Evaluate quality concerns of the performance of components from the production floor and/or field.

Respond to production quality concerns on a daily basis. Determine cause of concern.

Interface with production planning, engineering, purchasing and receiving inspection regarding vendor or customer rejects. Interface with all areas of performance testing.

Review product performance testing concerns and vendor rejects as required.

Assist in developing, implementing, maintaining and monitoring component and product testing.

Perform dimensional and other testing for special requests and items removed from the production floor or stores and placed on MRB.

Assist manufacturing and development engineering in developing and implementing testing of new components and new revisions of existing components.

Perform evaluation of product returned as a result of customer complaint.

Participate in developing necessary quality policies, manufacturing procedures, and inspection procedures to ensure the production and inspection of a quality product.

Participate in developing programs or projects that enhance the quality of the product.

Assist in development and execution of process/product.

Assist in the implementation, compliance and maintenance of ISO9001 and ISO 13485

Other responsibilities: Perform Internal Quality Audits as required Provide support for the equipment calibration and preventative maintenance programs. Review Engineering Change Order (ECO) requests as needed. Review of manufacturing processes to include determination of the necessity of process validation. Provide problem solving support to functional departments. Interact with external vendors regarding product concerns, vendor systems and operations concerns. Provide input into which type of equipment to purchase to satisfy inspection requirements. Provide QA support to product development teams for internal, as well as OEM products. Provide ongoing quality support to OEM customers. Perform other related tasks as requested or assigned.

Qualifications desired:
Four-year college degree in Engineering and 3-5 years minimum experience in a plastic injection molding or machine shop manufacturing environment or medical device company. Knowledge of FDA, ISO9001, ISO 13485, requirements. Knowledge of manufacturing and demonstrated ability with using ERP systems to enhance the QMS.  Knowledge of basic mechanical testing and material properties. Knowledge of Windows-Word, Excel, Microsoft Project, QC Calc or other SPC software. Well developed organizational and problem solving skills. Good communication and personal skills.

Compensation: 55 to 65k/yr depending on experience and qualifications. Excellent benefits package. If interested, please e-mail your resume to cbeckett@micronproducts.com.