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Quality Assurance Specialist @ Actalent

Greenville, North Carolina, USOnsiteContract
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About this role

Job Title: Quality Assurance SpecialistJob DescriptionIn this position, you will drive quality execution across medical device operations, including manufacturing, assembly, inspection, testing, packaging, and associated non-production-order-specific activities for commercial and product development products. Additionally, this position will provide quality guidance and expertise for implementing practical process improvements and continuous improvement initiatives. Typical hours are from 6 PM to 6 AM, on a 2-2-3 rotation. Responsibilities • Perform daily quality assessments of facility, personnel, manufacturing activities, and documentation to uncover errors or deficiencies and assure quality and compliance with site procedures, the Quality Management System (QMS), cGMPs, and applicable medical device regulatory requirements. • Interact daily with employees to assist with troubleshooting, documentation corrections/notes, and guidance on controlled manufacturing practices, contamination control, and adherence to approved work instructions. • Champion a quality culture by helping personnel understand and apply QMS procedures, quality policies, process controls, and applicable regulatory requirements. • Participate in quality event response (RAPID) and provide quality guidance for nonconformances, deviations, and other manufacturing quality events. • Escalate nonconformance and deviation events to the appropriate functional and Quality management teams. • Perform quality review and approval of procedures, work instructions, training documents, specifications, and forms of moderate to high complexity. • Perform quality review and approval of nonconformances, deviations, CAPAs, and change controls of moderate to high complexity. • Participate as the Quality Assurance representative in root cause analysis and investigations for nonconformances, deviations, complaints, and other quality events of moderate to high complexity, as applicable. • Perform quality batch record review. • Aid in identifying continuous improvement opportunities and participate in practical process and quality system improvement initiatives. Essential Skills • Bachelor’s degree, preferably in engineering, life sciences, technology, quality, or a related technical field. • Minimum of 4 years of experience in Quality Assurance, Quality Control, Engineering, or Operations/Manufacturing. • Previous experience in the medical device industry or another highly regulated manufacturing environment. • Experience working within an ISO-compliant quality management system and familiarity with applicable medical device regulatory requirements. • Ability to capture and analyze data and troubleshoot process, inspection/test, documentation, and equipment issues. • Hard-working, demonstrated ownership & responsibility. • Ability to lead, support, and empower a team/peers. Additional Skills & Qualifications • Professional certifications (e.g., CQA) and training (Six Sigma) are a plus. • Equivalent combinations of education, training, and relevant work experience may be considered. Work EnvironmentThe primary responsibilities require consistent production floor presence, which necessitates physical fitness for prolonged standing, walking, and repetitive bending. It also involves using required personal protective equipment and gowning appropriate to controlled manufacturing areas. Job Type & LocationThis is a Contract position based out of Greenville, NC. Pay and BenefitsThe pay range for this position is $15.00 - $27.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.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 TypeThis is a fully onsite position in Greenville,NC. Application DeadlineThis position is anticipated to close on Sep 18, 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 [email protected] 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.

Skills

quality assurancequality management systemcgmpdata analysistroubleshootingprocess improvementroot cause analysiscapateam leadershipsix sigmadocumentation control

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