Senior Quality Engineer — Lead Equipment Qualifications

Staar Surgical AG; Nidau; On-site; CHF 110,000 - 150,000; Full time

Benefits offered by this job

40 hours per week

25 days vacation

Modern cafeteria spaces

Free parking spaces

Good public transport links

Job summary

STAAR Surgical is expanding with a new manufacturing site in Nidau. We are recruiting a Senior Quality Engineer to support production, operations, maintenance and quality teams across equipment qualifications and validations.

The ideal candidate holds a Bachelor’s degree in Quality, mechanical, life sciences or industrial engineering and has several years of experience in medical device quality. Proficiency in English and IT tools is required; Kneat and Kaye Validator System knowledge is a plus.

Qualifications

• Bachelor’s degree in Quality, mechanical, life sciences or industrial engineering.
• Minimum two years’ experience or advanced degree with three years of experience in quality engineering, in the medical device or pharmaceutical industries. For Senior Position, minimum five years’ experience or advanced degree with three years of experience.
• Excellent English skills, both spoken and written. All other languages are an asset.
• Proficient IT Skills (e.g. MS Office, eQMS, etc.)
• Very flexible and adaptable to change with ability to work under pressure.
• Responsible, team oriented and well-organized personality.
• Knowledge of the Software Kneat is a plus.
• Knowledge of the Kaye Validator System is a plus.

Responsibilities

• Support site production, operations, maintenance, calibration and quality teams
• Prepare, execute, review and lead equipment qualifications and validations, technical studies, test method validations and other studies/reports
• Initiate and lead change assessments and impact assessments
• Manage equipment lifecycle requirements and impact assessments
• Serve as the quality representative during product or process investigation and during external and internal audits

Skills

Excellent English

IT skills

Team orientation

Organized

Adaptable to change

Education

Bachelor's degree in Quality, mechanical, life sciences or industrial engineering

Tools

Kneat

Kaye Validator System

Job description

STAAR Surgical is expanding with a new manufacturing site in Nidau. We are recruiting a Senior Quality Engineer to support production, operations, maintenance and quality teams across equipment qualifications and validations.

The ideal candidate holds a Bachelor’s degree in Quality, mechanical, life sciences or industrial engineering and has several years of experience in medical device quality. Proficiency in English and IT tools is required; Kneat and Kaye Validator System knowledge is a plus.