Job Summary: This position is responsible for the supplier quality management program. This encompasses the qualification and requalification process as well as the continuous evaluation for the global supply base. Support Global Product Development in determining critical material, packaging, product, and process characteristics; assist in the development and validation of test methods; assists in the development of test plans and validation protocols; and ensures adherence to the Rockline Product Development Process. This position will also manage the Quality Engineering program for new products and materials for Contract Manufacturing Services. In addition, this position will serve as a point person as the Quality System lead for our Springdale Technical Center, a registered FDA drug testing site.

Job Responsibilities:

• Conduct supplier quality audits including new supplier qualification audits and routine surveillance audits of existing suppliers.
• Align Rockline’s supplier management process across all business units, including developing global practices and procedures for supply chain activities.
• Assist Global Product Development and Contract Sales in developing and documenting material and finished product specifications. Ensure all specifications are properly controlled through the change management process.
• Assist Global Product Development in the development of test plans and validation protocols. Provide input for sampling plans, test methods, and acceptance criteria. Review and approve protocols and reports.
• Manage supplier audit program by developing and publishing yearly audit schedules. Assign audits to appropriate personnel.
• Coordinate continuous improvement of materials, process, methods and sampling to address variability. Establish or update internal standards (SOPs, sampling plans, etc) for the same.
• Manages and mentors staff to ensure their continued development. Provides technical and supervisory guidance as needed.
• Participate in supplier performance reviews providing supplier feedback on quality metrics.
• Serve as subject matter expert for Quality on cross-functional teams created to drive improvements to Rockline processes and systems.

Job Requirements:

• Bachelor’s degree in engineering or science required. Master’s degree highly desired.
• Minimum of five (5) years Quality Assurance experience in an FDA-regulated environment required.
• Minimum of two (2) years direct supervisory experience required.
• ASQ technical certification (CQE, CSSBB, CSSGB) highly desired.
• Experience managing and conducting supplier GMP audits and previous experience with quality systems auditing and validation for OTC drug and Class I medical devices highly preferred. International exposure is a plus.
• Previous experience in supplier quality management and product development quality assurance is preferred.
• Strong statistical background and analytical skills are highly preferred.
• Strong communicator, problem solver, and can be adaptable to travel up to 40% (dependent on the audit schedule), domestically and internationally.
• Proficient skills with Excel, Word, and statistical software.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)