Senior Supplier Quality Engineer

Job Title: Senior Supplier Quality Engineer

Job Description

This Senior Supplier Quality Engineer role focuses on ensuring the performance, quality, and operational readiness of contract manufacturers supporting ORS products. You will combine supplier oversight, sustaining engineering, project management, quality improvement, and new product introduction (NPI) leadership. Acting as a key interface between internal cross-functional teams and external suppliers, you will ensure compliant, scalable, and efficient manufacturing execution within a regulated medical device environment.

Responsibilities

• Act as the primary operational contact for contract manufacturers and serve as the main point of coordination for day-to-day operations.
• Partner closely with contract manufacturers to identify, investigate, and resolve manufacturing issues in a timely and effective manner.
• Coordinate directly with internal Quality and Engineering teams to align supplier activities with internal requirements and standards.
• Manage supplier performance across quality, delivery, and cost metrics, and drive corrective and preventive actions when performance gaps arise.
• Provide sustaining engineering support, including performing root cause analysis, executing corrective and preventive actions (CAPA), and supporting Material Review Board (MRB) activities.
• Lead supplier-related projects such as process transfers, IQ/OQ/PQ validations, and capacity expansions to support business growth and continuity.
• Support new product introduction (NPI) by contributing to supplier selection, developing requests for quotation (RFQ), and planning manufacturing readiness.
• Drive quality improvement initiatives with suppliers and participate in supplier compliance activities to maintain adherence to FDA, ISO, and internal quality system requirements.
• Collaborate across Quality, Research and Development (R&D), and Supply Chain functions to ensure cohesive planning and execution of supplier-related activities.
• Ensure supplier processes and documentation align with Device Master Records (DMR) and other manufacturing documentation requirements.
• Support remediation and continuous improvement efforts within supplier quality to strengthen overall supply chain robustness.

Essential Skills

• Experience working in medical device or regulated manufacturing environments, including familiarity with FDA and ISO requirements.
• Strong understanding of Device Master Records (DMR) and associated manufacturing documentation.
• Hands-on experience with manufacturing engineering activities such as injection molding, assembly, or electro-mechanical systems.
• Proficiency in root cause analysis and structured problem-solving methodologies.
• Experience working within a Quality Management System (QMS) in a regulated industry.
• Demonstrated capability in validation activities, including IQ/OQ/PQ for processes and equipment.
• 7–10 years of relevant experience in manufacturing engineering or supplier management.
• Proven track record of improving supplier quality and on-time delivery performance.
• Experience supporting new product launches and production transfers in a manufacturing environment.
• Strong ability to communicate effectively with suppliers, cross-functional teams, and executive stakeholders.
• Demonstrated project management skills and cross-functional leadership capabilities.

Additional Skills & Qualifications

• Bachelor’s degree in engineering, such as Mechanical, Manufacturing, Electrical, Biomedical, or a related field.
• Experience with medical device manufacturing processes and regulatory expectations.
• Familiarity with quality tools such as Failure Modes and Effects Analysis (FMEA) and Statistical Process Control (SPC).
• Experience with supplier quality management, including remediation and continuous improvement initiatives.
• Ability to work effectively in a growing organization and adapt to evolving processes and priorities.
• Strong interpersonal skills to build and maintain productive relationships with internal teams and external suppliers.

Work Environment

The role is based within a mid-sized medical device company, with the primary work location in R&D and office space. You will collaborate closely with engineering, quality, and supply chain teams in a professional, cross-functional environment. The position involves approximately 25% travel to supplier sites to support audits, issue resolution, validations, and project activities. The work setting emphasizes regulated medical device operations, structured documentation, and adherence to quality system requirements, offering the opportunity to contribute to a growing organization with potential for long-term engagement.

This is a Contract position based out of Wood Dale, IL.

The pay range for this position is $55.00 - $70.00/hr.

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)

This is a hybrid position in Wood Dale,IL.

This position is anticipated to close on Jul 24, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $55 - $70