West Pharma Quality Engineer 

Ireland, Dublin 

971746163

Job Summary:

Reporting toSenior 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:

• 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