Senior Manufacturing Quality Engineer

Kelly Science, Engineering, Technology & Telecom; Utah; On-site; USD 60,000 - 100,000; Full time

Job summary

This innovative firm is seeking a Senior Engineering Recruiter to enhance quality and drive results in the medical device industry. The role involves advocating for quality and lean methodologies, ensuring superior product quality, and collaborating with various stakeholders to resolve quality issues. As a key player in the organization, you will have the opportunity to lead process improvements and engage in risk management practices. If you are passionate about quality engineering and thrive in a regulated environment, this position offers a chance to make a significant impact in a dynamic field.

Benefits

Competitive pay

Paid holidays

Year-end bonus program

Recognition and incentive programs

Access to continuing education

Qualifications

• Experience in regulated environments like Medical Device or Aerospace is desirable.
• Proficient in risk management practices and tools, with expertise in process risk.

Responsibilities

• Ensure quality performance of products and processes in collaboration with operations.
• Lead development and improvement of manufacturing processes for new products.

Skills

Quality Engineering

Lean Methodologies

Communication Skills

Problem Solving

Analytical Skills

Risk Management

Statistical Techniques

Collaboration

Education

CQE or equivalent coursework

Tools

ISO 13485

GMP

Lean Six Sigma

Job description

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Senior Engineering Recruiter | Powering tomorrow’s innovations with today’s brightest engineering talent

Duration: 12 months - Estimated to end 4/2026 (Contract extension and/or internal hire possibilities)

Type: W2 contract (Third-party or C2C "Corp-to-Corp" arrangements WILL NOT be considered for this role)

Work Authorization: Must be currently in the United States with active employment authorization documents. Visa sponsorship is not available, now or in the near future, for this position.

Job Summary:

Seeking an experienced Quality Engineer with the ability to drive quality and deliver results. Someone who is an advocate for quality and lean methodologies; a self-directed professional who can identify issues and communicate effectively to all levels within the organization; a medical device industry professional who is passionate about providing superior quality products to patients and customers.

Duties include:

• Work closely with operations and the business functions to ensure quality performance of product and processes.
• Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
• Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
• Resolve quality issues with suppliers and partner with internal customers.
• Review and approval of change management activities.
• Maintain KPI for monitoring of process and supplier quality, perform analysis and interpret trends, take action as necessary.
• Ownership and reporting on all quality issues associated with assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders.
• Develop and provide input for risk management by identifying opportunities and weaknesses.
• Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions.
• Support execution and analysis of QATs.
• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.

Required:

• Previous experience in a regulated environment desirable (e.g. Medical Device, Aviation, Aerospace, Automotive, Defense).
• CQE or equivalent course work / experience desirable
• Proficient in understanding of Med Device manufacturing processes desirable.
• Familiarity with ISO 13485, GDP, GMP desirable.
• Proficient in risk management practices and tools, having high expertise in process risk.
• Proficiency in and makes continuous strides towards optimization of inspection methods and sampling.
• Lean Six Sigma training a distinct advantage.
• Excellent collaboration and communication skills and attention to detail. Able to effectively communicate up/down and across different levels of the organization.
• Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
• Highly developed problem solving and strong analytical skills.

Important information: To be immediately considered, please send an updated version of your resume to [e-mail].

*** (Kelly does not expense relocation/interview costs)**

Work Authorization: Must be able to work in the United States with current employment authorization documents without VISA status that requireVisa sponsorship now or in the future.

In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:

• Competitive pay
• Paid holidays
• Year-end bonus program
• Recognition and incentive programs
• Access to continuing education via the Kelly Learning Center

Seniority level

• Associate

Employment type

• Contract

Job function

• Engineering, Manufacturing, and Product Management
• Industries: Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Manufacturing