Description

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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.\tNew Product Developmenta)\tAssist in the quoting process by reviewing customer drawings and specifications for new product and providing feedback. b)\tCommunicate with customers to clarify requirements and resolve issues with manufacturing product. Provide design for manufacturing feedback to customers when appropriate. c)\tDevelop 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)\tWork with Manufacturing Engineers to create process routings for new product.2.\tContinuous Improvement and Daily Management a)\tUtilize 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. \t b)\tParticipate in continuous improvement projects/kaizen events. c)\tResolve quality issues using systematic, data driven problem-solving methodologies.d)\tEngage 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.\tProcess Development and Control. a)\tWork with manufacturing Engineers to develop process validation protocol, (IQ/OQ/PQ). b)\tUpdate control plans/inspection plans to ensure conformance to customer requirements. c)\tQuantify, document, and improve process capability using sound statistical methodologies. d)\tReview and approve internal ECOs to ensure conformance to customer specifications, and engineering standards.e)\tIdentify gaps in processes, and coach/mentor team to resolution. 4.\tNon-Conforming Material and Customer Returns a)\tParticipate in MRB (Material Review Board) meetings to investigate and disposition non-conforming material. Approve rework processes to correct non-conformities. b)\tCoordinate and document corrective actions generated for customer complaints/returns and internal non-conforming material.c)\tAssist in driving to root cause & developing preventative countermeasures.5.\tQuality Management System and Internal Auditsa)\tAssists in development and deployment of a world-class Quality Management System (QMS).b)\tPerforms risk assessments in the deployment of the QMS procedures. c)\tParticipate on the Internal Quality Audit Team as an Internal Auditor. d)\tAssist management representative during notified body, customer, and regulatory audits. Other duties as qualified and/or assigned.

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Skills

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medical device, gd&t, FMEA, process design, cmm programming, gage rr

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Top Skills Details

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medical device,gd&t,FMEA,process design

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Additional Skills & Qualifications

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•\tBachelor’s degree in an engineering or related scientific discipline; or 4-6 years of experience in a medical manufacturing industry engineering role.•\tAbility to effectively present information and respond to questions from managers, customers, and employees.•\tMust have a strong understanding of GD&T and the ability to translate it into working measurement methods.•\tThorough knowledge of blueprints and precision measuring equipment.•\tWorking knowledge of statistical quality tools (capability studies, control charts, gage R&R, ect.).•\tStrong technical writing skills.•\tCertified Quality Engineer (CQE) desired.•\tMust have continuous improvement mindset.•\tFamiliar with FMEA, Fishbone Diagram, PDCA Cycle.•\tEffective written and oral communications skills.•\tExhibit strong leadership, supervisory, interpersonal, and team building skills.•\tExcellent organizational & customer service skills.•\tAbility to prioritize and execute work on multiple projects.•\tStrong analysis and judgment skills.•\tWork well in a team environment as well as independently.•\tAbility to read, analyze, and interpret technical procedures or governmental regulations. •\tProficiency with SOLIDWORKS, Minitab & MS Office required (i.e. Word, Excel, Outlook).\t•\tExperience with CMM, and Video Inspection Systems desired.

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Experience Level

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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 for other accommodation options.