Senior Quality Engineer
Our client, a medical device company in County Kildare are currently looking to recruit a Senior Quality Engineer for their site.
- This position is accountable for the site Medical Device quality policies and procedures, interactions with Medical Device Customers and external quality/regulatory groups.
- In Medical Device Start Up's, this Role will be responsible for project management of all activities including, but not limited to, MVP development and execution, product licencing and clinical trial builds.
- In Operational Medical Device business, this Role will be responsible for activities including, but not limited to, leading audits, escalations, overseeing day to day line quality issues and identifying/leading projects to improve same.
- Site EN ISO 13485:2012 Subject Matter Expert (SME).
- Site Owner of Master Validation Plan
- Support audits from external regulatory agencies (FDA, HPRA) and customers and leads preparation activities in advance of such audits.
- Responsible for inputs into process change and process validations.
- Initiate / Approve Validation protocols and reports (IQ, OQ, PQ)
- Ownership of the sites Medical Device quality policies and procedures.
- Provide training as required on quality systems, eDMS and data analysis tools.
- Creates and evaluates metrics to drive the quality improvement process. Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, Cpk, R & R analysis, sampling techniques).
- Line Quality Plan owner.
- Ensure product design and manufacturing processes are optimised and controlled to generate product quality and reliability to meet all customer and regulatory requirements.
- Gathers, understands and converts customer data into usable manufacturing information.
- Use statistical knowledge and expertise to conduct process improvement studies in order to optimize production process and provide quality engineering support to the facility, including validation and risk management, and origination and review of technical documentation (e.g. FMEA).
- Evaluates (Risk Assessment, FMEA updates) software and hardware upgrades and new equipment. Sets equipment specifications and develops and runs qualification tests.
- Knowledge of, and adherence to, the company's Safety Statement and all aspects of safe working practices including, but not limited to, PPE, manual handling and chemical handling and awareness
- In-depth knowledge of EN ISO 13485:2012.
- Excellent customer contact, negotiation and problem resolution skills.
- Experience in the use of techniques such as Design of Experiments, Gauge R&R, Test Method Validation, sample size justification to support design changes, validations, deviations are required.
- Excellent interpersonal, written, and verbal communication skills; flexible; works well on a team; strong problem solving ability; good project management skills and excellent collaborative
- Ability to evaluate materials, gather and analyse data and determine root cause of problems.
- Ability to manage several projects simultaneously and coordinate multiple, changing deadlines.
- Min of 6 years' experience in a Quality Engineering role - essential
- Masters' degree in a related field - an advantage
- Project Management Experience - essential
- Lead Auditor Certified Training/experience conducting Quality Audits - Essential
- Experience of leading or participating in FDA, HPRA Audits - an advantage
- Experience of 6 Sigma methodology - an advantage
For further information on this Senior Quality Engineer role in County Kildare please contact Cliona O'Malley on 091730022 / firstname.lastname@example.org
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