Senior Quality Control Engineer

6 days ago


Suzhou, Jiangsu, China Roche Full time CN¥120,000 - CN¥180,000 per year

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Main Tasks & Responsibilities

Technical:

  • Support on developing instrument/lab material management and final product quality control strategy.
  • Support in time inspection execution and conduct the quality control test (includes but no limited to slides reader) for in-process and/or finished goods. And deal with complaints and continuous improvement, if necessary.
  • Ensuring Non-conforming execution following procedure
  • Draft, edit and review the instrument quality control related SOPs.
  • Ensure quality control records meet RDSZ requirements and related systems operation SOPs.
  • Collaborate closely with global, sending site and RDSZ site functions on continuous improvement of quality control procedures.
  • Lab material and Sample Management, e.g. inventory control, receipt of indirect material.
  • Coordination of lab safety, lab waste treatment, lab hygiene and lab equipment
  • Other duty as assigned by line manager.

Safety, Health & Environment

  • Ensure that all applicable Safety, Health & Environment requirements are fulfilled to comply with corporate group policy and local legal requirements.

Quality and Compliance

  • Ensure 'Right to Operate' through compliance with all global and local regulatory requirements applicable to RDSZ.
  • Implement and apply the RDSZ Quality Management System (QMS).

Product Supply

  • Maximize the service level to support uninterrupted supply of high-quality products.
  • Ensure that robust instrument quality control business processes are in place.

Continuous Improvement and Innovation

  • Establish and maintain a culture of continuous improvement that generates tangible contributions to site operational performance.

Qualification

  • A Bachelor Degree or above in manufacturing electrical, or mechanical engineering or equivalent by experience
  • 5 or more years 'work experience in the medical device or other related industries
  • Work experience in instrument quality control
  • Knowledge of SHE and quality regulatory requirements, especially in medical device
  • Strong technical acumen and communication skills
  • Strong negotiation / influencing / persuasion skills
  • Problem-solving skills with proven ability to anticipate issues and recommend effective and efficient solutions
  • Proficient knowledge of Mandarin and/or English (written & spoken)
  • Leadership competencies at proficient level, in line with corporate framework.
Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.



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