BEPC INCORPORATED

Occupation:

Regulatory Affairs Specialists\n

Location:

SAN ANGELO, TX - 76904

Job Type:

Regular, Full Time (30 Hours or More), Permanent Employment, Day Shift\n

Posted:

07/29/2026\nPositions available: 2\n

Source:

WorkInTexas\n

Web Site:

WorkInTexas\nOnsite /

Remote:

Work at home all of the time\n

Updated:

08/04/2026\n

Expires:

09/03/2026\nJob #: 17047943\nJob Requirements and Properties\nHelp for Job Requirements and Properties. Telework & Remote\nFull Time Education\nBachelor's Degree Experience\n36 Month(s) Age\n18 and up Schedule\nFull Time Job Type\nRegular Duration\nPermanent Employment Hours\n40 Hours Per Week Shift\nDay Shift Public Transit\nAvailable Benefits Help for . BEPC Inc. is a multinational company that provides professional services to the medical device manufacturing industry. BEPC, Inc. is seeking to hire two full-time Supplier Quality Auditors who are subject matter experts in the field of auditing across the complex and highly regulated manufacturing industries of medical devices, pharmaceuticals, biotechnology, microbiology, and sterilization sciences. Must have a profound understanding of key biophysical characteristics of thousands of raw materials and all the processes in the manufacturing supply chain, which includes understanding each medical device's unique design, mechanical, and electrical specifications. This knowledge is critical for ensuring compliance with the most appropriate packaging, labeling, storage, installation, and servicing of all finished medical devices.

Occupational duties further include:

Prepare, plan, schedule and create timelines for the completion of supplier audits. The planning and preparation phases involve extensive research into the study and analysis of past audit results of the supplier being audited. Auditor must draw upon technical knowledge/expertise and analysis of the supplier to effectively prepare for the audit. Apply scientific knowledge and specified regulations to the relevant industry being audited to execute medical device manufacturer supplier compliance audits that are in conformity with Current Good Manufacturing Practices, Good Laboratory Practices (GLPs), ISO, Federal Drug Administration, and similar international Quality System Regulations. Duty includes leading \"for cause\" audits of external suppliers. The duty includes ensuring the supplier's microbiological testing procedures are performed properly. These audits are focused on evaluating each supplier's manufacturing operations, quality control testing, laboratory testing facilities, and warehouse/distribution facilities to ensure compliance with customer and governmental regulations. Information collected during the audit must be critically analyzed to identify systems and process gaps and develop opinions/documenting observations regarding compliance risk. Prepare, summarize, and write technical audit reports, including nonconformance observations, trends, tables, graphs, and slides; issue audit reports; respond to positions set forth by suppliers, develop corrective/preventative action plans; and identify the patterns and trends of supply quality problems for review by the Supplier Auditing Manager. Review and evaluate supplier's audit responses against current industry and regulatory standards to ensure sufficient controls are in place to meet customer specifications. Auditor must also ensure suppliers have appropriate Corrective and Preventative Actions (CAPAs) in place for any deviations found in supplier manufacturing. Provide scientific and/or technical advice to suppliers and customers in regard to audit results and FDA compliance. Participate in the development of protocols/reports in support of test-method validations, design and process verifications and validations, biocompatibility, sterilization, shelf life, stability, and risk management. Auditor must also author and revise technical documents and procedures relevant to the auditing function. Conduct technical training. Auditor must also act as representative of BEPC when presenting audit reports to clientele, which includes preparation and presentation of presentations, verbal and audiovisual. Close audit after assessments and reports are finalized. Defend supplier practices during regulatory agency audits. Qualified candidates must have a bachelor's degree in engineering, science or related field (Foreign equivalent acceptable) and 36 months of experience in occupations relating to quality engineering or quality systems auditing. Qualified candidates must have certification in any one of several industry auditor training programs, such as American Society for Quality (ASQ) Certified Quality Auditor, Biomedical Auditor, Regulatory Affairs Auditor Certificate (RAPS), or ISO quality management certification.. Position may work from anywhere in the United States remotely because the work mostly involves conducting desktop audits of supplier manufacturers who are located in the United States and other global locations. Position also requires travel to visit suppliers to conduct on-site regulatory compliance audits in the United States and at other global locations. 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