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Description

This position is responsible for assisting daily production, work on continuous improvement of his/her department, participating to the LEAP activities like PSM, managing the customer complaints and the CAPA/NCR linked to his/her scope of activities, assuring compliance to and providing guidance regarding interpreting governmental regulations and ISO 13485 & FDA standards in link with the Manufacturing Quality Engineer activities. The Manufacturing QE acts as an Operational Lead for the QAR (Quality Representative) of his/her department. Primary Responsibilities: - For the Quality topics, assisting daily production and participating to achieve the APU objectives determined with the APU manager. - Create/Maintain updated quality plans and work instructions, inspection and control plans, inspection work instruction, PFMEA,… including the respect of quality requirements and standards. - Act as an Operational Lead with the QAR working in the same APU, which include but not limited to work with the Planner to define the inspection priority, manage the daily QAR PSM1, help to harmonize the QAR practices, escalation of issues when applicable. - The HR activities are supervised by the QA manager, in link with the Manufacturing QE such as defining the QAR training needs, preparation of performance reviews, problem resolution. - Identify continuous improvement opportunities and support efforts in order to implement LEAP principles throughout the organization, such as participating to PSM or LEAP workshop. - The NCR and the CAPA investigation linked to his/her APU, with respect to the due date define and using problem solving tools when applicable, and working as part of a cross-functional team. - Participate and be the QA lead for validation of equipment repairing with Maintenance, IT and the APU. - Interface with client and the supplier in case of Customer complaints or supplier SCAR. (Lead) - Transfer knowledge experience from the AO Quality Engineer when a project is mature enough to be considered as production phase. - Contribute to the APU employee training. - 6 sigma, statistical technics and 8D problem solving SMEs for his/her APU Secondary Responsibilities: - Train new employee for the Quality induction part. - Be back up of the other Manufacturing QE - Be the secondary backup of his/her APU AO QE. - Perform internal or external audits - Compile and analyze statistical data in order to assess process capabilities and control processes and conduct Process Failure Mode Effects and Analysis (PFMEA), Gauge Repeatability and Reproducibility (GR&R) and Statistical Process Control (SPC) studies.

Skills

NCR, Gd&t, Quality assurance, Medical device, gauge r&r, Quality engineering, Supplier quality, technical writing, work instruction, Iso 13485, blueprint reading, Corrective action plans, Quality management system

Top Skills Details

NCR,Gd&t,Quality assurance,Medical device

Additional Skills & Qualifications

- B.S. degree preferably in Manufacturing Engineering (or a related engineering field) - Minimum two years relevant experience / five years for senior position - Experience working within a CAPA program - Experience developing manufacturing quality plans - Experience conducting process capability, GR&R, PFMEA and SPC studies - Experience optimizing processes to achieve ongoing cost reductions - Experience working in an ISO environment, preferably ISO 13485 - LEAN / Six Sigma training and demonstrated application - Proficient PC skills in a Windows environment - Effective written and verbal communication skills - Strong interpersonal and teamwork skills

Experience Level

Entry Level

Pay and Benefits

The pay range for this position is $75000.00 - $95000.00/yr.

Employees and their families are eligible to participate in a comprehensive benefits package, including company-sponsored medical, dental, vision, flexible spending accounts (FSA), health savings accounts (HSA), voluntary benefits, supplemental life/AD&D insurance, and the company’s 401(k) plan. Additional benefits include access to an employee assistance program (EAP) for employees and household members, long-term disability coverage, and short-term disability for full-time employees. Full-time and Part-time employees receive Paid Time Off (PTO) based on years of service, as well as paid holidays, personal holidays and MN Safe and Sick Time

Workplace Type

This is a fully onsite position in Big Lake,MN.

Application Deadline

This position is anticipated to close on Apr 30, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.