Description The Quality Engineer develops and implements quality control plans, procedures, and inspection techniques to ensure conformance to customer specifications. Works with customers and suppliers to resolve issues of manufacturability to customer specifications. Investigates non-conformances to determine root cause and develop appropriate corrective/ preventative actions. Trains others and specifies inspection and testing techniques and equipment. Assists with formulating quality control policies and procedures. 1. New Product Development a) Assist in the quoting process by reviewing customer drawings and specifications for new product and providing feedback. b) Communicate with customers to clarify requirements and resolve issues with manufacturing product. Provide design for manufacturing feedback to customers when appropriate. c) Develop control plans for new product to ensure conformance to customer specifications. Create and document inspection instructions for quality control and production personnel to be trained to. Design custom gauging & inspection fixturing. d) Work with Manufacturing Engineers to create process routings for new product. 2. Continuous Improvement and Daily Management a) Utilize technical abilities and problem-solving methodology to solve manufacturing problems. Participate in problem solving methodology training to become a problem-solving coach/mentor to team members and leads. b) Participate in continuous improvement projects/kaizen events. c) Resolve quality issues using systematic, data driven problem-solving methodologies. d) Engage in Management for Daily Improvement process and support production as required to problem solve material, process, and equipment problems. Be the second line of defense to safety, quality, and delivery challenges in the value stream. 3. Process Development and Control. a) Work with manufacturing Engineers to develop process validation protocol, (IQ/OQ/PQ). b) Update control plans/inspection plans to ensure conformance to customer requirements. c) Quantify, document, and improve process capability using sound statistical methodologies. d) Review and approve internal ECOs to ensure conformance to customer specifications, and engineering standards. e) Identify gaps in processes, and coach/mentor team to resolution. 4. Non-Conforming Material and Customer Returns a) Participate in MRB (Material Review Board) meetings to investigate and disposition non-conforming material. Approve rework processes to correct non-conformities. b) Coordinate and document corrective actions generated for customer complaints/returns and internal non-conforming material. c) Assist in driving to root cause & developing preventative countermeasures. 5. Quality Management System and Internal Audits a) Assists in development and deployment of a world-class Quality Management System (QMS). b) Performs risk assessments in the deployment of the QMS procedures. c) Participate on the Internal Quality Audit Team as an Internal Auditor. d) Assist management representative during notified body, customer, and regulatory audits. Other duties as qualified and/or assigned. Skills medical device, gd&t, FMEA, process design, cmm programming, gage rr Top Skills Details medical device,gd&t,FMEA,process design Additional Skills & Qualifications • Bachelor’s degree in an engineering or related scientific discipline; or 4-6 years of experience in a medical manufacturing industry engineering role. • Ability to effectively present information and respond to questions from managers, customers, and employees. • Must have a strong understanding of GD&T and the ability to translate it into working measurement methods. • Thorough knowledge of blueprints and precision measuring equipment. • Working knowledge of statistical quality tools (capability studies, control charts, gage R&R, ect.). • Strong technical writing skills. • Certified Quality Engineer (CQE) desired. • Must have continuous improvement mindset. • Familiar with FMEA, Fishbone Diagram, PDCA Cycle. • Effective written and oral communications skills. • Exhibit strong leadership, supervisory, interpersonal, and team building skills. • Excellent organizational & customer service skills. • Ability to prioritize and execute work on multiple projects. • Strong analysis and judgment skills. • Work well in a team environment as well as independently. • Ability to read, analyze, and interpret technical procedures or governmental regulations. • Proficiency with SOLIDWORKS, Minitab & MS Office required (i.e. Word, Excel, Outlook). • Experience with CMM, and Video Inspection Systems desired. Experience Level Intermediate Level Pay and Benefits The pay range for this position is $48.00 - $65.00 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Monroe,WA. Application Deadline This position will be accepting applications until Dec 25, 2024. 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people 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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.