Lead Quality Assurance

Vor 6 Tagen

Nidau, Schweiz International Executive Service Corps Vollzeit
OBJECTIVE AND MAIN TASK OF THE FUNCTION

• Contribute in maintaining an effective and efficient QMS established at STAAR Surgical Company

• Plan, organize and perform internal and supplier audits

• Handle Document Control activities and ensure that quality system documents are issued, changed, approved, maintained and archived (hard copy and eQMS) according to the Company’s Document Control procedures.

• Ensure that the Company’s quality system documents and document control records are in an “audit-ready” state at all times.

• Handle the training process at STAAR Surgical AG and partner with the global Quality team to ensure its effectiveness and accuracy.

TASKS Quality Assurance:

• Plan and conduct internal audits, issue and present audit reports.

• Perform assessment and verification for effectiveness of corrective actions associated with audit observations and CAPAs.

• Collect and assess supplier qualification and purchasing data; maintain supplier qualification files, perform supplier audits.

• Key team member on 3rd party audits: monitor chats, retrieve documents, create copies, number and record documents. Keep records for requests, maintain logs and master file for 3rd party audits.

• Support external audits by regulators and customers.

• Ensure non-conformities are identified, corrected, and reported to the Corrective and Preventive Action (CAPA) system as needed.

• Perform Quality trainings.

• Collect and analyze quality system data.

• Participate in investigations and on cross-functional teams.

• Handle and review the training process at STAAR Surgical AG.

• Back up Quality Assurance Team members.

• Back up Quality Management within Quality Assurance and Document Control responsibilities.

• Support and assist with other tasks as assigned.

Document Control:

• Lead and coordinate Document Control team member(s) engaged in processing quality system documents through routing, reviews and approvals.

• Understand FDA and ISO Document Control requirements and ensure that the Company’s global Document Control procedures and practices meet these requirements.

• Partner with IT to ensure that the eQMS meets quality system requirements and Company needs.

• Ensure that quality system documents are issued, changed, verify documents were properly routed for approval and archived according to the Company’s Document Control procedures.

• Review documents for format, document changes, required attachments and enter applicable fields in the e-QMS ensuring they are completed correctly.

• Ensure documents are added to the Company’s document history files and design history files (hard copy and eQMS), according to the Company’s Document Control and Change Control procedures.

• Ensure document revisions have been accurately incorporated into the final version, all approvals have been received, and required attachments and forms are present prior to document release for distribution.

• Enter, document, update and maintain training requirements as instructed. Archive records in the e-QMS and/or hard copies according to the Company’s training and document control procedures.

• 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 new hire and on-going e-QMS training across sites, issue eQMS training tools if/as needed.

• Key team member on 3rd party audits, monitors chats, retrieves documents, creates copies, tags and numbers of documents.

REQUIREMENTS AND SKILLS

Education: Administrative Education

Special Knowledge: Mandatory: 3-5 years of experience in Quality Assurance

• English skills, both written and spoken

• French and/or German, both written and spoken

• Good IT knowledge in MS Office

Nice to have: Knowledge in ophthalmology

Personality: MS Word, Excel, Visio and Adobe Acrobat skills required. Experience with computer scanners, printers and general office equipment required. Proofreading skills and grammar required. Organizational skills required. Ability to learn how to use new tasks and duties as assigned. Ability to work as part of a team, communicate well with internal and external personnel, problem solve and work independently. Excellent organization and communication skills. Ability to work under pressure. Flexibility.

Professional Experience: Medical Device, Pharmaceutical or another ISO regulated industry is preferred.

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