Telephone: 086 8168298
Senior Quality Engineer
Our client, a medical device company in Cork are currently looking to recruit a Senior Quality Engineer for their site.
Key Technical Responsibilities:
- Develop effective Process Verification Strategies working with all product development cycle stakeholders.
- Work with the suppliers to produce quality process specifications as required during the development and implementation of new products. Approve design specifications (e.g. drawings, protocols) as defined for own scope of responsibility.
- Lead/support the implementation of new inspection technologies that achieve process reliability and productivity improvements with a focus on in-process inspection and Non-Destructive Testing (NDT)
- Establish a system of metrics to continually monitor measurable quality performance.
- Select, setup and establish calibration procedures for gages and equipment used in the Additive Manufacturing Process.
- Compile and execute validation protocols for new product/processes. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
- Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production. Provide statistical support for DOE (Design of Experiments), sampling plans, capability assessments, rationale development & hypothesis tests as required.
- Document and maintain in good order all relevant Quality documents. Deliver compliant transfers of Design History Files where required, ensuring transferred systems are understood and integrated into the Quality System.
- Supporting risk assessment activities: Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques to minimise potential risk during development/implementation activity.
- Ensure effective problem analysis/complaint investigation (CAPA) as required and define through negotiation effective corrective actions. Working with relevant business stakeholders, support and lead in the Non-Conformance (NC), Corrective And Preventative Action (CAPA) investigations and general problem solving for both design and process
- Liaise with R&D to ensure CTQ (Critical To Quality) specifications are agreed and documented for all NPD.
- Support Design for Inspection activities for all NPD to ensure latest technology is available to reduce Human factor.
- Support QA input in Design for Manufacture activities.
- Ensure consistency with other team QE’s, site Quality Systems and corporate Quality Systems. Ensure compliance with all Documented Quality system, as per FDA QSR’s and ISO 13485/9001 requirements etc. during day to day activities.
Education and Experience Minimum Qualifications:
- A degree level or similar qualification in mechanical or industrial engineering and 5 or more years related experience.
- Knowledge and appreciation of manufacturing processes and controls.
- Knowledgeable and experienced in managing supplier quality relationships; understanding how suppliers function, how our business interacts with theirs and how to plan, develop and monitor their process controls.
- Knowledge and understanding of process validation techniques such as risk assessment, validation planning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), change control and process verification.
- Must have a good understanding of Geometric Dimensioning and Tolerancing and be fully conversant with engineering drawings.
- Have the proven ability to interpret and create engineering specifications and procedures.
- Experience working in a regulated environment like medical device, automotive or aerospace. This includes knowledge of, and experience with, applicable standards, GxP requirements and regulations.
- Experience managing projects and demonstrating project leadership abilities.
- Strong interpersonal skills (Effective verbal and written communication)
- Must be PC literate, and familiar with MS Office applications.
- Knowledge of additive equipment and prior work experience in Additive Manufacturing.
- Experience with metallurgical process controls such as Heat Treating, NDT, and Welding.
- Knowledge of various metrology, measurement, and inspection techniques esp. NDE/inspection techniques suitable for 3D printed parts.
- Experience with CMM programming and familiarity with CT inspection systems.
- Advanced knowledge of Quality Engineering/Scientific Method techniques and principles.
- Strong technical understanding of manufacturing equipment and processes.
- Understanding of new product introduction processes.
- Experience implementing appropriate risk mitigation with knowledge of product and process Risk Management (FDA & ISO standards).
- Strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements.
- An advanced degree with Six Sigma, or ASQ Certification.
Specialized Q&C Competencies:
- Production and Processing Systems
- Qualification and Validation
- Product Design Support
- Quality Statistics, Data Analysis and Tools
- Product Control and Disposition
- Product Development Support
- Technical Transfer & Scale Up
- Predictive Analytics / Reliability
Other Skills, Experience and Education
- 5 yrs experience in a regulated environment.
- SIX SIGMA – Certification
- Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA)
- Experience of the design and qualification documentation standards to current FDA expectations
- Knowledge of statistical packages and Microsoft Office systems required.
- Proven ability to review and critique Quality Critical technical documents.
- A good understanding and working knowledge of FDA and ISO regulations. Desirable
- Knowledge of lean manufacturing
- Five years’ experience as Quality Engineer working in a cGMP environment preferably in medical device.
- Positive attitude
- Continuous Improvement orientation
- Accepting of change
- Flexible - Calmly reacts to the unexpected
- Credible – Accountable for decisions
- Self-Motivated – requires minimal direct supervision.
- Results focused – maximizes business benefit from all activities.
- Innovation – thinks laterally but within a compliant framework.
- Organized – Able to cope with extensive documentation and planning requirements.
- Six Sigma or quality engineer certified,
- Structured problem solving and decision making skills working in a team environment.
- Ability to participate in or leading cross functional project teams
- Must have good written and presentation skills and be able to communicate effectively throughout organization
- Demonstrated Experience working with data base applications desired
- Ability to set priorities while ensuring compliance is not compromised.
- Experience in performing Design of Experiments (DOE) and leading
For further information on this Senior Quality Engineer role in Cork please contact Niamh Hlubek 086 8168298 / email@example.com
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