Job Summary

Reporting to the NPI Senior Quality Engineer or Quality Work Package Manager. This role will support NPI projects and ongoing process revalidation with key focus around customer specification, Process Risk Management, Validation Master Plan, and protocol reviews. This person will provide the company with the technical and quality resources to manage the quality deliverables on selected NPI projects and day to day validation activities and will coordinate the necessary activities for ensuring the timely closure of internal/external quality issues on projects.

Essential Duties and Responsibilities

• Review and or approval of qualification and/or validation documentation (specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Validation representation.
• Review of validation documentation (protocols & reports) as a quality review against the signed off VMP and customer requirements.
• Review and approval of third party generated protocols and reports in conjunction with program Validation representation.
• Support development of Risk Management Plan in conjunction with Program Manager for the project covering quality, timeline, and commercial risks.
• Facilitate equipment process and / or Design FMEA and ensure, with the Program Manager, that the SMEs are trained to the FMEA process and updated on the relevant FMEA as required.
• Support development of Risk Summary Report (RSR) prior to the completion of the validation summary report.
• Support Test Method validation activities, computer systems validation.
• Participate in the review and disposition of all quality attribute and variable data for the program against customer specification / drawing e.g., Ppk’ s, Cpk’ s, FOT/FAT visual inspections.
• Lead investigations into material / product issues encountered throughout the development / validation lifecycle to ensure a thorough root cause, containment / corrective and preventive action is implemented, and learnings are taken into Operations.
• Drive the close out of change control, deviations, quality continuous improvements identified during the project.
• Drive solutions, in conjunction with the appropriate department, to ensure customer related problems/issues are communicated and corrective actions are in place and closed in a timely manner.
• Prepare data/presentations and attend quality review meetings with the customer.
• Support Process Output activities e.g., MSS, QSS, PSS and operational procedures review, approval.
• Set-up of Quality controls to ensure a smooth and effective handover to Operations e.g., Drafting of the defect library and QSS during OQ with formal hand over to Operational Quality prior to PQ; set up of incoming inspections for materials etc.
• Implement best practices principles into West QMS as applicable.
• Support internal and supplier audits. Play a key role in the preparation and hosting of third party and customer audits.
• Trending and tracking of quality data to drive improvements e.g., Sampling data, Maternal reviews reports, project protocols and reports.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations
• Compliance to all local site company policies, procedures, and corporate policies.
• Perform additional duties at the request of the direct supervisor.

Basic Qualifications

• Must have a third level qualification, at a minimum to degree level, in Engineering/Quality/Science.
• Must have a minimum of 3 years’ post graduate experience of working in a high-volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector.
• A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential.
• Must have an in-depth knowledge of validations in a Medical Device environment.
• An excellent understanding of plastic process manufacturing.
• Good understanding of computer system validation.
• Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab.
• Must have excellent communication skills both oral and written.
• Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred.
• Must be able to prioritize and organise tasks.

Preferred Knowledge, Skills and Abilities:

• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to always comply with the company’s quality policy.