Search Jobs

So sorry, this position is no longer available. Please go ahead and submit your application. We may have other positions that would be the perfect fit for you. Alternatively, you may want to apply to one of the following related jobs:

Brooklyn Center, MN 55430

Posted: 07/06/2026 Industry: Pharma/ Med Device Engineering Job Number: 26-92564 Pay Rate: 40-45 USD/Hour

Job Description

Join our team at the *** Energy and Component Center (MECC) located in the vibrant Brooklyn Center, MN. In this exciting role, you will have the opportunity to provide comprehensive manufacturing quality support for commercial medical devices within component manufacturing. This includes activities related to development, test method validation, process validation, inspection improvements, and process/quality change initiatives.
Responsibilities

Provide Software Quality Engineering support for new product commercial medical device component manufacturing lines.
Develop, modify, apply, and maintain quality standards and protocols for processing materials.
Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
Design or specify inspection and testing mechanisms and equipment;conduct quality assurance tests;and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
May specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.
Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.
Present technical data to groups within the organization.
Utilize quality tools including Risk analysis FMEA, statistical techniques such as six-sigma and DOE (design of experiments), root cause analysis, and reading and correcting drawings.

Additional Responsibilities

Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.
Defines appropriate measures to ensure product quality.
Develops overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.
Ensures that projects and process control documentation are compliant with requirements, objectives, and/or contracts.
Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
Reviews include applicable specifications, materials, tools, techniques, and methodologies.
Provides or directs verification and validation of software system requirements, traceability, and testability.

Qualifications

Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience.
Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.
Experience with Software Validation for equipment used in production.
Experience using SPC, CAPA, NCMR, PDP processes.
Working knowledge of Quality System Regulations such as (QSR 21 CFR 820), and ISO 13485: 2016.
Excellent verbal and written communication, analytical, influencing, and interpersonal skills.

Preferred Qualifications

DRM Greenbelt Certification

This position offers a full-time schedule of 40 hours per week, with the requirement to be on-site at the MECC Facility 4 days per week.

Meet Your Recruiter

Christopher Raj

Apply Now:

Apply Later

Share This Job:

Apply Online

Share This Job:

Related Jobs:

About Brooklyn Center, MN

Explore exciting job opportunities in and around Brooklyn Center, Minnesota! Nestled in Hennepin County, this vibrant area offers a perfect blend of urban conveniences and natural beauty. With easy access to the nearby Mississippi River and picturesque parks like North Mississippi Park, there are plenty of opportunities for outdoor adventures. The region boasts a rich cultural scene, from catching a show at the Historic Avalon Theater to exploring local art galleries like the Traffic Zone Center for Visual Art. Don't miss out on savoring the diverse cuisine options, from classic Midwestern dishes to trendy fusion eateries. Consider building your career in this dynamic area and discover the unique charm and growth potential Brooklyn Center has to offer.