Job
Description
Responsibilities may include the following and other duties may be assigned. Qualify suppliers according to company standards & management of approved supplier list per purchasing control compliance. Initiate and drives SCAPA's/NCR's to suppliers not performing/or adhering to company standards. Manage supplier change requests . Assesssupplier performance on periodic basis & drive necessary action for continous improvement. Establish a process & ensures that suppliers deliver quality parts, materials, and services. LeadPPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ & PQ methodology. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Provide pre-market quality engineering support to new product development (NPD) working in partnership with the component engineering and post-market supplier quality teams, to deliver quality parts, materials, and services, prevent defects, and allow company to provide customers with the highest quality and reliable products. Collaborates with component engineers to develop and deliver the product acceptance sampling strategy, approved supplier list coordination, supplier owned quality deployment, PFMEA,MSA, ,control plans andrelevant quality tools and methodologiesfor new products and legacy product. Define Receiving Inspection requirements as required and associated test method validation for all internal test methods. Conduct audits to qualify supplier's for intended use for the business as applicable. Must Have: Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of8+ years of quality systems experience. Experience in supplier management in medical domain is added advantage . Strong communication skills, both oral and written. Ability to comprehend principles of engineering, physiology and medical device use. Previous customer-facing and/or project management experience is a plus. Comfortable working with international and multi-cultural department and groups in different time zones . Accurate and delivers quality work, with a sense of urgency. Ability to work well under pressure and maintain positive, enthusiastic attitude. Ability to work in a fast-paced environment .Eagerness to learn and expand responsibilities & accountablity . Nice to Haves: Good interpersonal skills. Previous experience working with global team (Aerospace,Defence, Med device, automobile preferably). Ability to work effectively in a team environment and build strong working relationships. ASQ Quality certification CQE, CSQP, CQA. Working knowledge of Standard, Guidance, and Regulations. Hand on experience on Minitab tools . Exposure in auditing toFDA Quality System Regulation & ISO 13485. Lean Six Sigma Green Belt or Black Belt.
