Provide supervisory leadership for the Quality Management function in support of manufacturing operations. The position is headquartered in Alsip, IL with responsibility across North and South America. Duties are executed through the quality operations teams, with cooperation among GCA and intercompany Quality Assurance peers. RequirementsESSENTIAL DUTIES and RESPONSIBILITIES:
- Carry out the GC America QMS requirements for the QA Operations team and document these within the document management hierarchy (Quality Manual, Quality Assurance System Chart, and Quality Policies).
- Consult and support internal partners throughout the company on the creation & revision of procedures, to assure compliance with the QMS where applicable, within QA Operations scope.
- Manage the internal audit program for production & process control requirements including scheduling, execution, and reporting.
- Supervisor experience in managing small to mid-size teams with experience creating, motivating, leading, and evaluating the team to achieve department and corporate goals.
- Support third party audits; including facilitation of the audit schedule, preparation, hosting auditors, collection of evidence, and responding to audit findings.
- Support the preparation, analysis, and reporting for the QMS Management Review system according to procedure.
- Manage the preparation of standard and ad hoc reports and KPI data, as well as perform analysis of trends and submit findings to superiors and global peers.
- Lead and facilitate the implementation of daily management for QMS processes through the QA Operations staff; including Document Management, CAPA, Process/Product nonconformities, Complaint Handling, Finished Goods inspection & Batch Release, Inspection & acceptance of Incoming Materials, Quality Records storage & retention, and product batch retain management.
- Serve as a GCA QA representative for cross-functional and intercompany QMS related projects.
- Provide Quality Management System training, as needed.
- Participate in GQM improvement activities.
MINIMUM QUALIFICATIONS:
- BA/BS Degree in science, engineering or related field or equivalent supervisory and QMS experience in a Quality related role.
- 3+ years of experience in a regulated industry (Med Device, Pharma, Food, etc). Quality certification (ASQ, Lean, Six Sigma, etc.) is a plus.
- Supervisor experience in managing teams.
- Demonstrated competence in QMS requirements (ISO, FDA, GMP, etc.) and ability to comprehend and interpret complicated regulatory information.
- High level of working knowledge and understanding in the use of standard work / SOPs.
- The ability to communicate with peers in operations, partner and share information, but also hold nonconforming items, while engaging others on problem-solving activities.
- Skilled in Microsoft Office 365 tools and technology (Word, Excel, PPT, etc).
- Skills with QC tools & techniques is highly preferred (Control Charts, Histograms, Pareto diagrams, Cause & Effect diagrams, Process Flow Diagrams, Check sheets, Scatter Diagrams, etc.)
Salary Description $70,000-$85,000