Our client, a global leader in medical devices is recruiting for a Supplier Quality Engineer for their site in Shannon for a 6-month contract.
The Supplier Quality Engineer drives project deliverables for component and process receiving inspection set up. Provides technical support in the execution of equipment, and inspection infrastructure along with suppliers ASL set up.
- Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.
- Works with team to establish and maintain the Supplier approval Schedule and perform supplier qualification per established timelines.
- Provides guidance to suppliers in new product introduction (NPI) activities in order to establish robust manufacturing processes to provide highest quality product.
- Primary engineering support for receiving inspection processes and material set up. Drives improvement and corrective action in the quality of components sourced from outside suppliers to eliminate recurrence of non-conformances.
- Establishes incoming inspection procedures/processes while designing/developing and/or sourcing inspection tools and equipment. Train inspectors to said procedures and practices and assists in generating component specifications. Work to resolve supplier technical issues in a timely manner to ensure continuity of supply.
- Applies knowledge of process control tools, investigational, and analytical techniques (i.e. DMAIC, SPC, DOE, cause and effect, reliability, etc.) to support data driven decisions.
- Developing a network of internal/external resources to facilitate/ Influence completion of tasks through situational Leadership.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts while implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and company specifications.
- Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
- Leads organisational and cross functional teams to achieve objectives
- Has advanced communication skill and solicits inputs and involve others in decision making.
- Actively communicates and questions things to learn and to share ideas for improvements.
- Possesses knowledge of techniques like six sigmas, Gage R&D studies, process capability measurement tools (Cpk), lean manufacturing, sampling plans and statistics.
- Knowledge of print/specification and geometric dimensioning and Tolerancing.
Qualifications and Experience:
- Bachelor of Science in Engineering, Technology, Science or Equivalent.
- 0-5 Years of increasingly higher levels of engineering experience
- Manufacturing Process Controls expertise.
- Demonstrated understanding of QSR and ISO standard requirements for processes and in-depth and professional level of knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards including ISO 13485.
- Material/Purchasing Controls, Product Realization, Validation and CAPA.
- Ability to work independently, very organized, advanced communication skills and self-driven.
- ASQ Certified Supplier Quality Professional or Certified Quality Engineer
- Problem Solving Subject Matter Expertise; Project experience with Packaging, Sterilization Validation, Calibration and Analytical Labs.
- Understanding of Quality Agreements
- Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred.
- Ability to manage work with a positive attitude while working in a fast-paced manufacturing environment.
- Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.
- Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and effects analyses is strongly preferred.
- Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
- Medical Device Industry expertise
- Possess manufacturing experience in the following processes:
- Injection moulding
For further information on this Quality Engineer role in Shannon please contact Orla Crowley on 0860449473/ Talent@hero.ie
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