Supplier Quality Engineer
The Supplier Quality Engineer role will include:
- Responsible for delivering component inspection set up for designated project.
- Assess potential new suppliers for technical, quality and manufacturing capabilities.
- Provide technical support for the introduction of components from a new supplier.
- Establish and maintain the Supplier approval Schedule and perform supplier qualification per established timelines.
- 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 Lifescience specifications.
- Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
- Possesses knowledge of techniques like six sigma, Gage R&D studies, process capability measurement tools (Cpk), lean manufacturing, sampling plans and statistics.
- Knowledge of print/specification and geometric dimensioning and tolerancing.
- Travel Required: 0 - 24%
Supplier Quality Engineer Minimum Qualifications:
- 5 years med device 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.
- Medical Device Industry expertise
- Manufacturing experience.
At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details.
This position was pPosted on 10 Mar 2020