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【美资500强 Life Science BU】招聘Quality Manager-苏州吴江
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【美资500强】招聘Quality Manager-工作地点：苏州吴江 Life Science，产品：生化实验室耗材 有意者请将简历发至：chriss.ye@talent2.com Job Description： Ensures that plant’s products meet customer requirements and that the plant has an up to date and capable Quality Control system, including all procedures, specifications and equipment required for the Quality Control function. Collaborates with the Commercial group to resolve customer complaints and to translate customer requirements into meaningful product specifications. Develops processes and systems to prevent quality problems. Day to Day Responsibilities: • Manage the receivership of transfer products • Build & Manage plant quality systems (including ISO documentation, records retention, etc.) and plant quality personnel to ensure that the plant’s products meet all customer requirements • Responds quickly and effectively to customer complaints and issues. Serves as the customer advocate in the plant. • Collaborates with plant and division innovation teams to evaluate new product needs and translate them to meaningful plant specifications. Identifies and • Defines all required measurement protocols. Works with process and product improvement teams regarding key product attributes to develop appropriate control strategies and feedback loops to make sure product attributes perform as expected. • Continuously improves quality function spending to help the plant lower its costs. • Manages department spending and budgets. • Determines impact of proposed product specification changes to yield and/or costs • Leads project teams to resolve and permanently fix customer complaints. • Perform process capability analysis as needed. • Provide statistical design and analysis services to internal plant departments. • Oversees all customer quality audits of the plant. Leads corrective action teams to resolve audit deficiencies. Education & Experience Required • Bachelor of Science or equivalent degree • Successful and proven supervisory, team leadership or mfg experience • Demonstrated leadership capability; ability to influence others, act with integrity • Solid business acumen, capable of making quality business decisions • Results orientation; ability to manage projects • Demonstrated ability to drive results within quality infrastructure Desired • Quality Assurance Professional with extensive experience in the pharmaceutical and biotechnology industries • Significant knowledge of GMP, FDA, ISO Standards, China medical devices regulations • Certified Quality Auditor (CQA) or with proven ability to manage internal, vendor, client and regulatory audits. • Known for successful implementation of corrective and preventive action program (CAPA) in dealing with deviations and complaints • Knowledge of product sterilization requirement and process • Experience auditing suppliers and service providers such as irradiation (Gamma & E-Beam) and packaging companies • ASQC (American Society of Quality Control) certification (or equivalent) |
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