Senior Quality Engineer
Our client, a medical device company in Kildare are currently looking to recruit a Senior Quality Engineer for their site.
- Reporting to the site General manger, this position has site wide oversight for the Quality Management System including the role of Management Representative for any FDA manufacturing and inspections
- The incumbent will be a subject matter expert (SME) for medical device manufacturing and provide oversight and expertise to all Medical Device related quality policies and procedures.
- The incumbent will lead regulatory discussions and audits with potential new customers in Medical Device segment and external quality/regulatory groups where applicable.
- In operational Medical Device business, this Role will support escalations and provide input and expertise.
- Authority to escalate any significant quality non-conformances event above site management to corporate regulatory authority
- Monitors site performance to ensure ongoing conformance to the Quality Management System
- Site EN ISO 13485:2012 SME and lead upgrade to 2016 standard.
- Provide expertise input and approvals to Master Validation Plans for each Business Unit
- Lead audits from external regulatory agencies (FDA, HPRA, ANVISA, PMDA) and customers and leads preparation activities in advance of such audits.
- Ownership of the sites Medical Device quality policies and procedures.
- Oversight and final approver for critical activities such as CAPA, Change Control, Risk Assessment, Design, Validation, Control Plan reviews
- Provide training as required on quality systems, audit, eDMS and data analysis tools.
- Creates and evaluates metrics to drive the quality improvement process.
- SME for appropriate statistical techniques to monitor process performance (e.g. SPC, Cpk, R&R analysis, sampling techniques).
- In-depth knowledge of 21 CFR parts 807, 820, 803, EN ISO 13485:2012. Knowledge of the Pharmaceutical regulations including 21 CFR 200-211 is desirable.
- 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.
- Ability to effectively communicate & collaborate with a wide variety of internal and external customers.
- Works well on a team with proven ability in building excellent cross functional relationships
- Ability to evaluate materials, gather and analyse data and determine root cause of problems.
- Strong Project Management skills & ability to manage several projects simultaneously and coordinate multiple, changing deadlines.
- Min of 9-15 years' experience in a Quality Engineering role in Medical device manufacturing - essential
- Min of 4 FDA inspections as the Quality Manager.
- Degree qualification minimum in a related field - essential
- Lead Auditor conducting Quality Audits essential, with experience of FDA/HPRA audits highly desirable
- Experience of 6 Sigma methodology. Ideally a 6 sigma black belt.
- Project Management Training/Experience - an advantage
For further information on this Senior Quality Engineer role in Kildare please contact Bimi Felix on 091730022 / firstname.lastname@example.org
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