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.

Job Type & Location

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

Pay and Benefits

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…