Quality Assurance Lab Technical Specialist

Job Description Job ID#: 5811 Job Category:

QUALITY

Position Type: Permanent Full Time Duration: DirectTechnical Solutions Inc. is currently seeking a Quality Assurance Lab Technical Specialist on behalf of our client, a manufactured based in the Pittsburgh area. The Quality Assurance Laboratory Technical Specialist holds primary authority over the execution, technical oversight, and integrity of laboratory testing activities supporting product quality, regulatory compliance, and risk management within the Quality Management System (QMS). This role functions as the technical backbone of QA lab operations, ensuring that test methods, equipment, and data generated meet the requirements of 21 CFR 820 (QMSR), ISO 13485, and relevant product-specific standards (e.g., IEC 60601, ISO 10993, ISO 11607).Duties:Test Method Execution and Technical OversightPerforms and provides technical direction for incoming, in-process, and finished device testing, ensuring methods are executed in accordance with validated procedures and approved specifications.Equipment Qualification and CalibrationMaintains authority over laboratory equipment qualification, calibration scheduling, and maintenance to ensure measurement traceability and data integrity.Method Validation and VerificationLeads or supports test method validation/verification activities, ensuring statistical and technical rigor sufficient to support product release and regulatory submissions.Data Integrity and DocumentationReviews and approves laboratory data, test records, and reports for accuracy, completeness, and compliance with Good Documentation Practices (GDP), serving as a technical checkpoint before data is used to support disposition decisions.Nonconformance and Investigation SupportProvides technical expertise during laboratory-related nonconformance investigations, root cause analysis, and CAPA activities, including assessment of out-of-specification (OOS) or out-of-trend (OOT) results.Risk Management SupportContributes laboratory testing data and technical rationale to risk management files (ISO 14971) and supports verification/validation activities tied to design controls.Job RequirementsSkills and Qualifications:Bachelor's Degree or equivalent experienceMinimum of 3 years' experience in a medical device setting (preferred)Excellent verbal and written skillsAbility to work in a fast-paced environment with the ability to manage multiple, simultaneous responsibilities.Additional skills: Process Improvement, Analyzing Information, Attention to Detail, Thoroughness, Dealing with Complexity and controversyTechnical Solutions Inc. provides a wide range of staffing services throughout Western Pennsylvania, Ohio and West Virginia. Simplify the job search process by letting us do all the work! With 30 years of expertise, we have the resources, techniques and insights to guide your job search. Our staff will work with you one-on-one to understand your needs and discuss your options. We can even send your resume to multiple job openings that you are a fit for, giving you opportunities to choose from. We reach out to hiring managers for feedback, coordinate and schedule interviews, and advocate on your behalf so that you get the best offer possible. At TSI, we genuinely care about our employees and want to see you succeed. No candidate is ever promised something we do not deliver. The best part is that there are no fees or cost for any of our services. For more information on our company and to view all of our exciting job opportunities, please visit or give us a call at View phone number on click.appcast.io.