Document Control and Quality Assurance Coordinator 100%

STAAR Surgical Switzerland; Brügg; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

40 working hours a week

Minimum 25 days of vacation

Training and development plans

Free parking spaces

Good connections to public transport

Social company events

Zusammenfassung

STAAR Surgical AG in Nidau is expanding its Quality department and seeks a motivated Document Control and Quality Assurance Coordinator (100%). You will organize and archive quality system documentation, ensure GDP compliance and support audits across sites.

The role requires QA knowledge, excellent English communication, and strong attention to detail with proficiency in MS Office. German/French language skills are a plus, and the position offers a stable full-time 100% schedule.

Qualifikationen

• Quality assurance knowledge required.
• Strong written and spoken English communication.
• German and/or French language skills are a plus.
• Proofreading and grammar skills.
• Excellent IT skills with MS Office.
• Attention to detail and adaptability under pressure.

Aufgaben

• Organize, index and archive quality system documentation per procedures.
• Review quality documents for GDP compliance and completeness.
• Ensure proper routing, approvals and archiving of documents in the system.
• Maintain and update training records and generate training reports.
• Assist with audits and support for Regulatory Affairs tasks.
• Act as Document Control Lead when required.

Kenntnisse

Quality Assurance knowledge

English communication

German/French language asset

Proofreading

MS Office proficiency

Attention to detail

Under pressure/adaptable

Jobbeschreibung

Our company is further expanding by setting up a brand-new manufacturing site located in Switzerland. In order to reinforce our Quality department in Nidau, we are currently recruiting a motivated colleague for the position as

Document Control and Quality Assurance Coordinator 100%

Your responsibilities

Document Control Activities

• Organize, index, file, maintain and archive quality system documentation, both hard and electronic copies, as directed and in accordance with Company procedures for document and record control
• Review quality system documents for completeness and for compliance with Good Documentation Practices (GDPs)
• Verify and ensure that quality system documents are issued, changed and properly routed for approval and archived according to the Company’s Document Control procedures
• Review documents for format, document changes and required attachments, enter applicable fields in the eQMS and ensure that they are completed correctly
• Ensure document revisions have been accurately incorporated into the final version, all approvals have been received, required attachments and forms are present prior to document release for distribution
• Enter, document, update, maintain and archive training requirements as instructed, maintain hard copy training records, provide training reports to departmental managers as needed
• File and maintain documents and records according to the Company’s record retention procedure, prepare documents and arrange for off-site storage and retrieval as needed
• Provide eQMS training to new hires
• Supporting member on 3rd party audits
• act on behalf of Document Control Lead when required

Quality Assurance Activities

• Provide Certificate of Conformity upon request of customer service
• Support various Regulatory Affairs related tasks performed within STAAR Surgical AG responsibility
• Provide new hire and on-going eQMS training across sites, issue eQMS trining tools if/as needed

Your profile

• Quality Assurance knowledge is required
• Very good communication in English – spoken and written
• German and/or French is an asset
• Proofreading and grammar skills
• Very good IT knowledge in MS office
• Attention to detail, adaptable to change with ability to work under pressure

The right decision: working at STAAR Surgical

STAAR Surgical offers you the ideal environment to develop your career and to progress professionally and personally, within a multicultural and international company. We also offer the following benefits:

• 40 working hours a week
• Minimum 25 days of vacation
• Training and development plans
• Free parking spaces as well as very good connections to public transportation
• Regular social company events such as summer party/winter party