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, and 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, e.g., 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, e.g., Quality Specification Sheets (QSS), CAPAs, Defect Library, etc.
* Trending and tracking of quality data to support quality improvements across the business.
* Lead investigations into material/product issues to ensure a thorough root cause, containment, and 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 with all site Environmental, Health and Safety requirements, training, and regulations.
* Compliance with 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, or Science.
* Must have 2+ years of 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 and SPC.
* Must have excellent communication skills, both oral and written.
* Auditing experience to the requirements of ISO 13485, EU GMP, or 21 CFR Part 820 is preferred.
* Ideally have a working knowledge of Lean or 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 exert up to 10 lbs / 4 kg of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
* Mental Requirements: must be able to communicate with other members of the team and other departments, be a quick decision-maker, and have knowledge to interpret data.
Delegation of Duties:
When absent from the site, duties and responsibilities will be delegated to the following designates:
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