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Responsibilities:
Maintaining and continuously improving the QM System at CLS ensuring that QA practices and procedures are appropriate and in compliance with regulatory requirements
Leading the non-conformance process; identifying, evaluating, and documenting internal failures and reporting on trends
Identifying and initiating action to reduce potential risks to safety and reliability such that effective counter measures/corrective actions are identified, implemented, and closed out in a timely manner
Leading investigation activities of significant non-conformances, including root cause analysis (TapRootTM), ensuring consistent process and timeliness of completion
Directing the performance of internal audits; developing, implementing and monitoring performance measures for auditing and inspection functions
Creating, reviewing and updating QA documents within document control to ensure accuracy and consistency of documentation which includes manuals, records, plans and inspection reports
Producing and presenting reports to management as well as external regulators and/or stakeholders
Ensuring process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation
Developing quality centered training materials for delivery to all levels of employees
Collaborating on related programs and training materials
Communicating with staff routinely, clarifying areas of QA focus, promoting three-way communication and resolving employee concerns
Participating in supplier, customer/user and regulatory audits
Developing effective partnerships and relationships internally and externally as necessary to support the achievement of QM System program and service objectives