Sr.Quality Assurance Engineer

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, majoring in electronic engineering, automation, biomedical engineering, mechanical engineering, quality management or other related science and engineering fields.

• At least 5 years of working experience in quality assurance or related fields for active medical devices, working experience in an international company is preferred.

• Be familiar with product quality management and process validation and new project transfer process.

• Have independently led or deeply participated in at least one product R&D transfer and production process confirmation project.

• Be familiar with ISO13485, China GMP and other regulatory, experience with QSR820 is preferred.

• Understand the safety regulations related to active medical devices (such as IEC 60601-1) and EMC requirements.

• Proficient in root cause analysis (such as 5Why, fishbone diagram) and CAPA tool.

• Good communication and teamwork skill.

• With responsible, and careful personality.

Operating Company:

DEXIS

Envista 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.