Supplier Quality Engineer

Job Title: Supplier Quality Engineer

Job Description

The Supplier Quality Engineer plays a key role in ensuring quality excellence and regulatory compliance across manufacturing operations. In this position, you support site inspection readiness, material movements, client audits, and supplier quality and material compliance activities. You collaborate closely with suppliers and internal stakeholders to ensure products meet the highest standards while contributing to a culture of continuous improvement and compliance. This role directly supports the mission of enabling customers to make the world healthier, cleaner, and safer.

Responsibilities

• Support site inspection readiness activities to ensure ongoing compliance with FDA, EMA, and other cGMP regulations, as well as client-specific requirements.
• Oversee and support material movements to ensure that incoming materials and components meet established quality and regulatory requirements.
• Participate in and support client audits, regulatory inspections, and internal audits by providing documentation, responses, and subject matter expertise related to supplier quality and quality systems.
• Work directly with suppliers to resolve supplier quality issues, including investigation, root cause analysis, and implementation of corrective and preventive actions.
• Manage and track Supplier Corrective Action Requests (SCARs), ensuring timely closure, effectiveness verification, and appropriate documentation.
• Review and oversee supplier-initiated change controls, assessing impact on product quality, regulatory compliance, and supply continuity.
• Conduct and support risk assessments, including use of tools such as FMEA, to identify, evaluate, and mitigate risks associated with suppliers, materials, and processes.
• Implement, maintain, and improve supplier quality management processes in alignment with corporate quality policies and regulatory expectations.
• Ensure effective use of quality systems, including change control, deviation and CAPA management, document control, and training systems, to maintain a robust quality management system.
• Support validation and qualification activities related to suppliers, materials, and processes, ensuring adherence to validation and qualification protocols.
• Contribute to process improvement initiatives that enhance quality, efficiency, and compliance across the supply base and internal operations.
• Prepare, review, and maintain quality documentation, including procedures, specifications, audit reports, and risk assessments, ensuring accuracy and regulatory compliance.
• Collaborate with cross-functional teams such as manufacturing, engineering, regulatory, and procurement to align on quality expectations and resolve issues.
• Communicate effectively with internal teams, external suppliers, and regulators to provide clear updates, reports, and recommendations on supplier quality performance.
• Use statistical analysis and quality tools to monitor supplier performance, identify trends, and drive data-based decision making.
• Manage multiple projects and priorities simultaneously, ensuring timely completion of quality-related activities and deliverables.
• Support a culture of continuous improvement by identifying opportunities to strengthen quality systems, processes, and supplier relationships.
• Travel up to approximately 25% as needed for supplier visits, audits, and cross-site collaboration.

Essential Skills

• 7-10 years of experience in Quality Assurance with a Bachelor's degree in a STEM field, or an advanced degree with at least 3 years of experience, or a Bachelor's degree with at least 5 years of experience in quality assurance within a regulated industry.
• Experience in pharmaceutical, medical device, or biotech industries, with a preference for pharmaceutical experience.
• Experience working in a GMP or other regulated environment.
• Strong knowledge of cGMP and applicable regulatory requirements, including FDA and EMA expectations.
• Hands-on experience with quality systems, including change control, root cause analysis, deviations, documentation management, and training systems.
• Experience with electronic Quality Management Systems and electronic Training Management Systems.
• Demonstrated expertise in CAPA and deviation management, including investigation, implementation, and effectiveness verification.
• Experience with change control processes for materials, suppliers, and processes.
• Proficiency in risk management methods, including FMEA and related risk assessment tools.
• Experience in internal and external auditing, including supplier audits and support for regulatory or client audits.
• Background in supplier quality management, including supplier qualification, performance monitoring, and issue resolution.
• Experience with validation and qualification protocols related to processes, equipment, or suppliers.
• Proficiency with quality management software and MS Office applications.
• Strong regulatory compliance knowledge and ability to interpret and apply regulations to practical situations.
• Advanced problem-solving and root cause analysis skills applied in a quality or regulated environment.
• Excellent project management abilities, including planning, prioritization, and coordination of multiple tasks.
• Strong verbal and written communication skills for effective interaction with internal teams, suppliers, and auditors.
• Ability to work both independently and collaboratively within cross-functional teams.
• High attention to detail while maintaining an ability to see the broader process and business context.

Additional Skills & Qualifications

• Bachelor's or advanced degree in Engineering, Life Sciences, Chemistry, or a related technical field.
• ASQ certifications such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) are highly desirable.
• Knowledge of statistical analysis and quality tools for monitoring and improving supplier and process performance.
• Experience in documentation and risk management, including creation, review, and maintenance of controlled documents.
• Experience with validation oversight and understanding of qualification requirements for regulated processes.
• Strong interpersonal skills for effective cross-functional collaboration and relationship building with suppliers.
• Additional language skills beyond English are beneficial for working with global suppliers and partners.
• Motivation to contribute to large-scale biologics and chemistry operations that support the manufacture of proteins and other components used in pharmaceutical products, including therapies for autoimmune diseases.
• Interest in working within an organization that values innovative thinking, impactful work, and continuous professional development.

Work Environment

This role is primarily office-based with desk work in a professional setting. The position follows a Monday-Friday schedule with standard daytime hours, while offering flexibility as long as core hours are covered. You will work within a fast-growing, global organization focused on large-scale biological and chemistry pharmaceutical operations, supporting the production of biologics such as proteins used in pharmaceutical products. The culture emphasizes doing things the right way for the right reasons, with the customer at the center of decision-making. You will collaborate with colleagues who are dedicated to impactful work, including helping customers find cures for serious diseases, protecting the environment, ensuring food safety, and supporting critical health solutions. The organization invests significantly in research and development and provides resources, tools, and opportunities to help you realize your full potential and build a meaningful, long-term career.

Job Type & Location

This is a Contract to Hire position based out of Saint Louis, MO.

Pay and Benefits

The pay range for this position is $38.00 - $48.00/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)

Workplace Type

This is a fully onsite position in Saint Louis,MO.

Application Deadline

This position is anticipated to close on Jun 26, 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.