Quality Engineer

4 months ago

Dublin, Ireland West Pharmaceutical Services Full time

Job Summary

:

Reporting to the Senior Quality Engineer within Operations this role ensures internal system compliance and customer specifications conformity. This role will ensure the timely and effective closure of internal/external quality issues.

Essential Duties and Responsibilities:

Interface on an ongoing basis with customers to ensure requirements / concerns/complaints are communicated and corrective and preventive actions are closed in a timely and effective manner. Management of customer documents into the West Quality system ie Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel. Drafting and approving of quality documentation to meet West and Customer requirements ie Quality Specification Sheets (QSS), CAPA’s, Defect Library etc. Trending and track of quality data to support quality improvements across the business Lead investigations into material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented. Adherence to incoming control requirements and supporting the SCAR process when required. Participate in the review of validation protocols and reports to ensure quality compliance. Executing internal process and system audits. Manage quality projects in support of continuous improvement e.g., Lean Projects. Co-ordinate activities associated with change management and customer interaction. Ensuring the timely and effective closure of day-to-day quality issues. Interface with other departments on a daily basis. Batch paperwork review and final decision to release product for shipment. Analysing and reporting of key measures e.g., Ppk’s, Cpk’s, Cost of Quality, Customer Complaints, and Internal/external quality results. Coach and drive a culture of compliance and continuous improvement. Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct. Compliance to all site Environmental, Health and Safety requirements, training and 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 in Engineering/Quality/Science. Must have 2+ years work experience in a Medical Device manufacturing environment. A working knowledge of quality systems such as ISO 13485 is essential. Experience and knowledge of 21 CFR Part 820 and EU GMP is an advantage. Ideally have an understanding of plastic process manufacturing. Must have an in-depth knowledge of validations and change control management in a Medical Device environment Must have a working knowledge of statistics & SPC. Must have excellent communication skills both oral and written. Auditing experience to the requirements of ISO 13485 / EU GMP / 21 CFR Part 820 is preferred. Ideally have a working knowledge of Lean / 6 Sigma tools.

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.

Travel Requirements:

Must be able to travel up to 5% of the time.

Physical and Mental Requirements:

Physical Requirements: must be able to be exerting up to 10lbs / 4kg of force occasionally, and / or negligible amount of force frequently or constantly to life, carry, push, pull or otherwise move objects. Mental Requirements: must be able to communicate with other members of the team and other departments, be quick decision maker, have knowledge to interpret data.

Delegation of Duties:

When absent from the site duties and responsibilities will be delegated to the following designates:

Senior Quality Engineer Quality Assurance Manager

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