Title:  Quality Engineering, Team Leader

Job Summary

Quality Engineering, Team Leader oversees projects, maintains processes and addresses quality issues by analyzing outcomes and collaborating with teams for effective resolutions. This position will continue the QA routine activities of a working WSS lab and QA duties for future business.

Essential Duties and Responsibilities

• Contribute to the development and implementation of quality management programs focusing on continual improvement across various processes.
• Create processes to better evaluate, track and trend audit outputs and identify risks/issues and evaluate impact on global quality systems and initiate actions, as needed.
• Coordinate communication between internal teams.
• Regularly analyze data trends, drive improvements and meet customer expectations through efficient reporting and communication.
• Reviews, revises, and creates operating procedures to ensure compliance with all related external requirements, internal procedures or instructions, and the West Quality Manual.
• Ability to lead meetings with relevant teams, employees and contractors as necessary to manage changes.
• Establishes monthly KPI’s and metrics to Quality Leadership.
• Drive continuous quality improvement projects across the enterprise for increased compliance and to create efficient use of company resources.
• Leading personnel responsible for calibration activities monitoring, calibration reports approvals. Responsible for calibration specifications approval and for reviewing and approving calibration deviations.
• Lead the site’s device sterilization methods establishment, validation, maintenance and routine controls as the site sterilization SME by verifying that the sterilization methods validation is done according to the applicable standards and regulations. Verify the sterilization methods and risk-based approach are routinely maintained. Address sterilization issues and provide solutions to sterilization challenges. Be a part of the West Global Sterilization Council and provide support to other West CM and Medical device sites with Sterilization issues. Be key focal point with the West IL sterilization service providers related to sterilization matters.
• Independently performs supplier audits and corporate facility audits

Additional Responsibilities

• Data Reviewer: - Review and approve laboratory procedures, work instructions, ESOPs, EWIs, PFNBs, protocols, forms, method transfers, reports, analyst analytical training, etc. - Review all WSS documentation for compliance to West and/or Client policies and procedures, cGMPs and applicable ISO standards. Investigations: - Liaise and collaborate with the WSS departments/clients to initiate, investigate, review and approve OOS investigations and reports and any other lab investigations as deemed necessary. - Conduct root cause analysis and issue appropriate corrective action when deemed necessary. - Work/interface with Lab personnel for continuous improvements related to CAPA and/or customer or regulatory requirements. Audits: - Plan, host and co-ordinate Customer, ISO, Corporate QA, and Regulatory audits/inspections of WSS facilities. - Coordinate the responses to customer audit observations, customer complaints and request for information/documentation. - Assure execution of internal quality audits, according to established procedures for the assigned areas / locations. - Provide response to audit observations, and customer complaints and inquiries.

Education

• Bachelor's Degree In Engineering or Science required and
• Master's Degree In Engineering or Science preferred

Work Experience

• Minimum 5 years Experience in regulated Quality Assurance / Document/Configuration Control (or a formal education equivalent) required and
• Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities preferred and
• Experience with quality systems such as ISO 9001, ISO 15378 and ISO 13485, 21 CFR 820 preferred and
• Experience Leading Internal / External Audits, MasterControl, SAP and Share Point preferred and
• Experience with customer interface and meeting customer expectations preferred

Preferred Knowledge, Skills and Abilities

• Ability to work independently, multi-task and thrive in fast-paced environment.
• Excellent written and verbal communication skills
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Proven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485.
• Familiarity with root cause analysis tools
• Working knowledge of MasterControl and SAP
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual
• Able to comply with the company’s safety policy at all times.

License and Certifications

Travel Requirements

Physical Requirements

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual
• Approval of calibration certificates and deviations
• Reviewing and Approval of Bioburden and dose audit reports.