Quality Engineer – Osseo

Requirements:

Individual selected will provide solid Quality Engineering & Project Management experience for the Alliance Quality Management organization in support to pre-commercialization new business alliance projects and existing post-commercialization business accounts. Pre-commercialization support consists of due diligence audits of potential acquisition or distribution/co-distribution suppliers with respect to QSR/ISO, data assessment (DHF, product reliability, risk management, etc.), and proposing/implementing needed issue mitigation plans. Post-commercialization support consists of supplier visits/audits, quality data review for risk management and mitigation, continual improvement, change control review and approval of validated process, and active support to management review and complaint management. Individual will be responsible for the development and execution of business solutions to protect BSC and its customers. Individual will be required to apply extensive technical expertise and develop/implement technical solutions to complex problems which require knowledge of QSR/ISO and Quality Engineering principles. Individual will exercise considerable latitude in determining technical objectives and solutions of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results. Individual interacts with senior external personnel on significant technical matters often requiring coordination between organizations. Capable of working with and quickly understanding gaps from alliance partners systems and BSC’s then developing solutions for these. Individual must be capable of quickly establishing and maintaining positive relationships when degrees of Quality expectations differ.

Individual must possess high attention to detail, problem solving skills, knowledge of regulations and standards. Excellent written and verbal communication skills are essential. Individual must be able to communicate and interact with all levels of executive, management, and operational staff. Excellent negotiation skills and tenacity to achieve high degrees of Quality overall are a must.

B.S. in Engineering or Related Technical Field. Minimum of 3+ years Quality Engineering experience in QSR or ISO regulated environment. Medical device experience strongly preferred. ASQ-Certified Quality Engineer and/or Certified Quality Auditor preferred. Proven track record in developing and implementing effective process controls. Knowledge of and effective application of quality tools (e.g., Six Sigma) expected.

Up to 50% travel required. Occasional international travel is probable.

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