QMS Auditor (Internal & Supplier) – North America

BEPC is actively looking for a QMS Auditor (Internal & Supplier) – North America!

W2 Contract - 6 months with possible extensions!

Benefits include medical, dental, vision, and life insurance

Compensation: $28.00 - $33.00/hour – Determined based on experience

Work Arrangement: Remote role - Travel required based on business needs

Note: This is a W2 only role — C2C, C2H, will not be considered.

BEPC is seeking a highly motivated QMS Auditor (Internal & Supplier) to join our client’s site in San Angelo, TX. This role will support internal quality system audits as well as supplier quality system audits for Fortune 500 Medical Device Companies located in North America. Audits may be conducted both on-site and remotely to applicable quality management system standards. The QMS Auditor will conduct supplier audits across industries including Medical Device, Biotechnology, Microbiology, and Sterilization Sciences as needed to meet customer requirements, as well as internal company QMS audits. The QMS Auditor must have strong written and oral communication skills in English to conduct supplier audits.

Summary of Duties and Responsibilities:

• Conduct internal quality system audits and supplier quality system audits.
• Perform both on-site and remote audits to applicable quality management system standards.
• Conduct audits for suppliers across industries such as Medical Device, Biotechnology, Microbiology, and Sterilization Sciences.
• Apply practical scientific knowledge relative to the industry being audited.
• Lead teams of auditors as required.
• Maintain qualifications and certifications required for audits in applicable regions and territories.
• Collaborate with all levels of management.
• Build and maintain professional positive relationships with all groups.
• Travel as needed to meet customer and business needs.

Qualifications:

• Education: Bachelor’s degree (or regional equivalent) in a technical field or engineering.
• 3–5 years’ experience auditing medical device companies and/or associated supplier quality systems.
• Minimum of 7 years of auditing experience.
• Ability to effectively speak, write, and read in English and regional languages as applicable.
• Thorough knowledge of QMS auditing principles and techniques.
• Leadership skills to work and collaborate with all levels of management.
• Self-directed.
• Proficient in Microsoft Office tools such as MS Word and Excel.
• Excellent written and verbal communication skills.
• Thorough knowledge and understanding of standards and regulations such as: ISO 9001 | ISO 13485 | ICH-Q7 | 21 CFR 820 | PAL | ANVISA | ISO 14644 | 21 CFR 4 | ISO 17025 | 21 CFR 58 | Other applicable regulations.

Preferred Qualifications:

• Technical/science degree.
• Lead auditor certification(s) preferred, such as: ASQ CQA or CBA: ISO 9001/13485.
• Prior experience working in and/or auditing laboratory activities is desirable.

Supervisory Responsibility

• This position is an individual contributor position.

Work Environment

• Operates in a professional office environment.
• Routinely uses standard office equipment such as laptop computers and smartphones.

Position Type / Expected Hours of Work

• Typical schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m. Central Time.
• Agility and quick response time to customer and employee requests may be required, including evenings and weekends.
• Travel: Able to travel as needed to meet customer and business needs.

About BEPC:

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

Apply Now!

Qualified candidates are encouraged to apply by submitting an up-to-date resume that highlights how your experience aligns with the role. Please include specific examples that demonstrate your qualifications. We look forward to connecting with you!