SUPPLIER QUALITY ENGINEER

Spherion Staffing, LLC; Warsaw (IN); Remote; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, Prescription, Dental, Vision

AD&D and life insurance

Short-term disability

401K plan

Job summary

Spherion Staffing, LLC is seeking a detail-oriented Supplier Quality Engineer II for a remote, nine-month contract in the United States. You will guide quality improvements, collaborate with suppliers, and ensure compliance with QSR/ISO standards on medical device projects.

Ideal candidates have 5+ years in medical device quality, CQE or CRE certification, and strong GD&T, CMM, and blueprint reading skills. Working hours are 7:00 AM - 4:00 PM with comprehensive benefits post hire.

Qualifications

• 5+ years in a Quality Engineering role within Medical Device industry
• Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) through ASQ
• Thorough knowledge of medical device product lines and benchmarks

Responsibilities

• Evaluate process methods and equipment to ensure performance and quality requirements are met.
• Establish quality plans for equipment and processes tailored to product needs.
• Monitor process performance against established quality standards.
• Apply ISO and QSR requirements to internal processes and supplier operations.
• Partner with suppliers on new product introductions to meet quality metrics.
• Assist Manufacturing, Sourcing, and Development in regulatory interpretation.
• Develop and manage department and project budgets.

Job description

Terms

I am at least 18 years old

I am legally authorized to work in the United States

We are seeking a detail-oriented and results-driven Supplier Quality Engineer II to join a high-impact quality initiative. In this remote 9-month contract role, you will be responsible for gathering factual data to solve complex quality issues, ensuring process methods meet rigorous regulatory standards, and collaborating with key suppliers to ensure flawless product delivery. If you are looking to leverage your medical device quality expertise on a critical project, this is an outstanding opportunity to make an immediate impact.

Responsibilities

• Evaluate process methods and equipment to ensure all performance and quality requirements are consistently met.
• Establish comprehensive quality plans for equipment and processes tailored to general and specific product performance needs.
• Monitor ongoing process performance against established quality standards.
• Apply ISO and Quality System Regulation (QSR) requirements to internal processes, procedures, and supplier operations.
• Partner with suppliers on new product introductions to guarantee all quality and performance metrics are fulfilled.
• Assist Manufacturing, Sourcing, and Development teams in the interpretation and application of regulatory standards.
• Develop and manage department and project budgets effectively.

Working hours: 7:00 AM - 4:00 PM

Skills

• Industry Experience: 5+ years of experience in a Quality Engineering role within the Medical Device industry.
• Certifications: Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) through the American Society for Quality (ASQ).
• Domain Knowledge: Thorough knowledge of medical device product lines and competitive industry benchmarks.

Education

• Bachelors

Experience

• 4-7 years

Qualifications

• Education: Bachelor??'s degree in Engineering (or an alternative Bachelor??'s degree with a Certified Quality Engineer / CQE certification).
• Technical Proficiency: Expert knowledge of blueprint reading, Geometric Dimensioning and Tolerancing (GD&T), and Microsoft Office Suite.
• Testing & Tools: Demonstrated ability to use optical comparators and Coordinate Measuring Machines (CMMs).
• Regulatory Knowledge: Solid understanding of QSR/ISO regulations, design assurance, Failure Mode and Effects Analysis (FMEA), product testing methods, statistics, process control, and process capability.
• Core Competencies: Strong oral and written communication skills across organizational levels, proven deadline-driven execution, and the ability to evaluate technical data accuracy.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].