Your Job

Responsible for normal operation of the Quality laboratory, instrument calibration process, inspection of the NPI phase and production phase, including the arrangement of incoming, in-process and outgoing inspection on time.

What You Will Do

1. Responsible for the management of QC leader, Quality technician and inspector, including resource planning, training, coaching, qualification and performance review.

2. Responsible for daily management of Quality lab to comply with the GLP guildlines, including manpower, equipment/instruments, sample, data and environment.

3. Rensponsible for the qualification for the test equipment & test method.

4. Responsible for the calibration and preventive maintenance of measuring or monitoring equipment.

5. Project Process validation or revalidation execution, including MSA, process capability study etc.

6. Data analysis to monitor the process stability or continue improve the control process, including inspection data, environmental monitoring data, deviations, CAPAs etc.

7. Non-conforming material/products handling, MRB meeting organizer; support the CI team to do the continuous improvement.

8. Management of all non-conformities occur in quality lab and inspection teams.

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9. Other duties as assigned by supervisor.

Who You Are (Basic Qualifications)

Required: College degree

Preferred: Bachelor or above degree. Major in Mechanical

Manufacture and Production Engineering

Technology.

Required

• Knowledge in GMP and ISO13485.

• Good communication skills, fluent English both in written and oral, strong problem solving skills, the knowledge of FMEA/SPC/QC 7 tools.

• Good analytic senses

• Experienced in measurement.

• Knowledge in statistics.

Preferred 优先: CMM/OGP programing

CMM/OGP

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

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At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.