• Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product.

• Leads Internal and Supplier Audits for Medline, ensuring internal procedures and FDA/ISO requirements are met for Medical device/drug products.   Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full spectrum of Medline products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories. Perform internal audits of Medline divisions and manufacturing sites. Lead complex, critical, supplier regulatory projects involving cross-functional teams.

• Ensures CAPA and SCAR documentation from suppliers and internal partners are received on time per procedures and are adequate.  Lead and Mentor auditors on the internal audit team and conduct trainings for the team as required on new updated regulations.

• Identify and manage the execution of continuous improvement projects. Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint.

• Maintain professional relationships with Medline division QA and suppliers, while enforcing industry regulatory requirements based on product classifications and audit agenda.   Attend Audit escalation meetings and oversee/review audit observations for applicability and merit.

• Minimum 5 years working in senior level quality role within medical device or pharmaceutical manufacturing. - Experience with FDA regulations (21 CFR 820, 21 CFR 210/211). - Experience with ISO 13485. - Experience applying knowledge of process validation, method validation and sterilization processes.

• Knowledge / Skills / Abilities - Detail-oriented, with excellent oral and written communication skills. - Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions. - Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary. - Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines. - Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally).

Management responsibilities include:

• Oversee Internal audit team of auditors, maintain audit schedule and maintain audit team metrics.

• Support Day-to-day operations for Audit team.

• May have limited budgetary responsibility and usually contributes to budgetary impact;

• Interpret and execute policies for departments/projects and develops.

• Recommend and implement new policies or modifications to existing policies (update procedures for internal audit, supplier quality).

• Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

Qualifications:

Education

• Bachelor’s degree in Engineering, Science, or Technical Field.

Work Experience

• At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).

• Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)

• Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.

• Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.

• Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating apivot table).

Preferred Qualifications:

• At least 4 years of supervisory/managerial experience in Quality or Regulatory Affairs teams.

• Experience in Auditing for Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries with a focus on QMS in regulated industry.