Supplier Quality Engineer (Medical)

ICDS Recruitment

Mayo

Supplier Quality Engineer - Co. Mayo. fixed-term contract. Job Summary: Effectively encourage and motivate associates to be successful and remain focused on Quality, Service, Cost and Safety objectives compatible with company's Mission and Vision. Responsible to manage supplier quality and auditing, oversee supplier certification, conduct raw material issue resolution, execute incoming process improvements, and provide support on Quality Engineering projects. Key Responsibilities: Supervise the day to day operations of the Receiving Quality Inspection Laboratory. Develop laboratory personnel including periodic appraisal of each employee’s performance and training. Maintain strong line of communication with all laboratory employees, keeping all personnel informed with periodic updates on objectives and plant performance. Oversee all chemical and physical testing required by product specifications. Knowledgeable of all analytical capabilities within the laboratory and applies knowledge to ensure compliance with specifications and effective problem solving of material related issues. Lead investigations and problem solving of raw material and in-process non-conformances with plant personnel and/or suppliers. Purchase, install, qualify and maintain laboratory test equipment used for raw material testing. Visit supplier facilities, conduct supplier audits, train supplier personnel in inspection of materials, and represent quality during joint meetings with suppliers. Interface with supplier quality representatives concerning problems with quality assurance and ensure that effective corrective action is implemented. Act as the primary QA contact with suppliers on all quality related issues during both the supplier maintenance and supplier selection process. Provide supplier related support to production and receiving inspection team. Write and implement standard operating procedures to meet and maintain FDA QSR, ISO 13485 Quality System Standards. Champion the continuous improvement of quality in order to fulfill customer and market requirements. Lead cross-functional teams to identify root cause and implement corrective actions to resolve raw material issues. Troubleshoot laboratory, testing, and material issues as needed. Empower team employees and hold individuals accountable for maintaining a safe work environment and safe work behaviours in the inspection areas with regards to material handling, fork lift operation and any appropriate personal protective equipment. Responsible for achieving competency in all identified skill requirements outlined in associated training profile for position. Interested applicants should have at least2-5 years' relevant experience. Medical device, pharmaceutical industry or biotechnology experience, perhaps working in a chemical and physical testing laboratory, preferably in support of manufacturing. Supervisory experience preferred with excellent independent judgement and interpersonal skills. Excellent mathematical, written communication and verbal communication skills. Strong technical writing skills and attention to detail. Knowledge of and proficiency in the use of basic statistics. Familiarity with Good Manufacturing Practices and FDA Regulations. Knowledge of ISO 13485 and FDA CFR Part 820 preferred. Supplier Auditing experience. ASQ Certified Quality Auditor a plus. Knowledge of ERP Systems preferred. This job originally appeared on RecruitIreland.com.

2011 days ago