Document Control and Quality Assurance Coordinator

International Executive Service Corps; Lavamünd; Hybrid; EUR 42.000 - 56.000; Vollzeit

Zusammenfassung

International Executive Service Corps is seeking an experienced administrator with strong quality assurance exposure to manage document control and regulatory tasks within a medical device/pharma environment.

You will handle eQMS document flows, training coordination, archiving, and support internal audits. Candidates should have 4+ years in admin/QA, fluent English, and MS Office proficiency.

Qualifikationen

• Education: Administrative education.
• Strong English skills, both written and spoken.
• French and/or German (written and spoken) is a plus.
• Very good IT knowledge in MS Office; Quality Assurance knowledge required.
• Proofreading and grammar skills.
• Organizational and communication skills.
• Adaptable to change with ability to work under pressure.
• Learning attitude and logical approach.

Aufgaben

• Process documents routed for approval in the eQMS.
• Assign eQMS training tasks and maintain training files.
• File, maintain and archive documents and records according to the company procedures.
• Initiate DCOs for document updates.
• Document Control and QA point of contact.
• Provide administrative support for Regulatory tasks.
• Support QA tasks and 3rd party audits.
• Act on behalf of Document Control Lead when required.

Kenntnisse

Attention to detail

Proofreading

Organizational skills

Communication skills

Adaptable under pressure

Learning attitude

Logical approach

MS Office proficiency

Strong English skills

French/German knowledge

Ausbildung

Administrative education

Tools

MS Office

Jobbeschreibung

OBJECTIVE AND MAIN TASK OF THE FUNCTION

Primary responsibility resides in the following areas/activities:

• Process documents routed for approval in the eQMS
• Assign eQMS training tasks as needed and maintain training files
• File, maintain and archive documents and records according to the Company’s record retention procedure
• Initiate DCOs for document updates
• Document Control and Quality Assurance point of contact .
• Provide administrative support for Regulatory tasks
• Support and assistance to other quality assurance tasks

TASKS

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
• Initiate DCOs for document updates
• Provide eQMS training to new hires
• Supporting member on 3rd party audits
• act on behalf of Document Control Lead when required
• other duties as assigned

Quality Assurance Activities

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

REQUIREMENTS AND SKILLS

Education: Administrative education

Special Knowledge: Strong English skills, both written and spoken

French and/or German (written and spoken) is a plus

Very good IT knowledge in MS office, Quality Assurance knowledge required

Personality: Attention to detail

Proofreading and grammar skills

Organizational and communication skills

Adaptable to change with ability to work under pressure

Learning attitude and logical approach

Professional Experience: Minimum 4 years of experience in Administration and Quality Assurance, preferably within Medical Device and/or Pharmaceutical fields