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Senior Quality Engineer

Job Title: Senior Quality Engineer
Contract Type: Permanent
Location: Kildare
REF: 89018
Job Published: about 1 year ago

Job Description

Contact: Bimi Felix
Telephone: 091730022

Senior Quality Engineer
Our client, a medical device company in Kildare are currently looking to recruit a Senior Quality Engineer for their site.

Position Summary/Scope:
  • 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.
Key Responsibilities:
  • 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).
Core Knowledge/Skills/Competencies:
  • 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.
Typical Experience/Education:
  • 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 /
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