Job Description
Technical Solutions Inc. is currently seeking a Quality Process Auditor on behalf of our client, a manufacturer based in the Pittsburgh area. The Quality Process Auditor holds primary authority to independently plan, conduct, and report on internal and supplier audits of the Quality Management System (QMS) to verify ongoing compliance with 21 CFR 820 (QMSR), ISO 13485, EU MDR 2017/745, and other applicable regulatory and customer requirements. This role functions as an objective, independent evaluator of process effectiveness and regulatory conformance, operating with the authority to access all relevant records, processes, and personnel necessary to complete a thorough audit, free from undue influence by the areas being audited.
Duties:
Audit Planning and Execution
- Develops and executes the internal audit schedule and audit plans based on risk, process criticality, and regulatory requirements, ensuring full QMS coverage within required cycles.
Independent Evaluation of Compliance
- Assesses processes, records, and practices against applicable procedures, standards, and regulations, with the authority to identify and formally document nonconformances regardless of organizational level or department.
Supplier and Contract Manufacturer Audits
- Plans and conducts audits of suppliers and contract manufacturers to verify their quality systems and processes meet applicable requirements and contractual quality agreements.
Audit Reporting and Escalation
- Issues audit reports with findings classified by severity and holds authority to escalate critical or systemic issues directly to Quality and executive management independent of the audited function's chain of command.
CAPA Verification
- Verifies the adequacy and effectiveness of corrective and preventive actions arising from audit findings, with authority to reject closure of CAPAs that do not demonstrate effective root cause resolution.
Regulatory and Certification Body Liaison Support
- Supports external audits and inspections (Notified Body, FDA, ISO certification bodies) by providing audit history, trend data, and QMS status, and may participate as a host or technical resource during external audits.
Audit Program Improvement
- Identifies trends across audit findings to inform management review inputs and drive continuous improvement of the QMS.
Quality Process Auditor Skills and Qualifications:
- Bachelor's Degree or equivalent experience
- Minimum of 3 years' experience in a medical device setting (preferred)
- Excellent verbal and written skills
- Ability 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 controversy
Technical 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 www.tsiwork.com or give us a call at 724-733-2100.
Numbers & Facts
| Location | Pittsburgh, PA |
| Industry | Staffing/Employment Agencies |
| Company Size | 10 to 19 employees |
| Year Founded | 1991 |
| Website | https://tsiwork.com/ |
About Company
Technical 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 over 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 www.tsiwork.com or give us a call at 724-733-2100.
Skills
- Auditingunmatched
- Code of Federal Regulationsunmatched
- Continuous Improvementunmatched
- Contract Manufacturingunmatched
- Contract Requirementsunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Detail Orientedunmatched
- External Auditunmatched
- FDA (Food and Drug Administration)unmatched
- ISO (International Organization for Standardization)unmatched
- Internal Auditunmatched
- Medical Equipmentunmatched
- Medicineunmatched
- Needs Assessmentunmatched
- Presentation/Verbal Skillsunmatched
- Process Analysisunmatched
- Process Improvementunmatched
- Quality Managementunmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Riskunmatched
- Trend Analysisunmatched
- Vendor/Supplier Evaluationunmatched
- Writing Skillsunmatched
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.
Free resume templatesFree resume builder
Improve your existing resume or start from scratch and create a standout, ATS-friendly resume. Add job-specific content, download and apply.
Free resume builder