Quality Lead

Jiangsu
Permanent
Full-time

2 days ago

Job Description:Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards. May be responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development. May manage process and product non-conformances in line with company procedures. May conduct quality assurance tests to ensure product specifications are met. May review, investigate, resolve and report on quality discrepancies. May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards. May monitor, investigate, and report on customer complaints. May obtain the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development. May lead audit and inspection preparation, resolution of audit and inspection findings. May have frequent interaction with other functional areas and operating entities.Job Requirements:

Bachelor’s degree or above with Good English skill both in written and oral.
At least 6 years product quality management working experience in international medical device company, or 10 years quality management experience in industry.
Be familiar with product and process quality management and new project quality management.
Be familiar with ISO9001, ISO13485 and relative medical device regulations.
ISO9001, ISO13485和其他医疗器械法规
Good communication and teamwork skill.
Team management/lead experience

Operating Company: Nobel BiocareEnvista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

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