Document Control & Compliance Specialist - Hybrid

Zimmer Biomet; Warsaw (IN); Hybrid; USD 51,000 - 63,000; Full time

Job summary

Zimmer Biomet seeks a document control specialist to manage records and ensure compliant documentation. You will train peers, author new documents, and lead change control activities to support timely processing of requests.

Ideal candidates have 1–3 years in QA/compliance within medical devices, knowledge of 21CFR 11/820 and ISO 13485, and experience with eDM systems; Windchill experience is a plus. Hybrid on-site work in WARSAW IN preferred.

Qualifications

• BS/BA in engineering, business, life sciences or a similar discipline required.
• 1–3 years of experience in Quality Control, Quality Assurance or Compliance, preferably in document control in the medical device or life sciences industry.
• Working knowledge of 21CFR Parts 11 and 820, ISO 13485 QMS.
• Experience with electronic Document Management (eDM) systems preferred.
• Prior experience with compliance audits or inspections preferred.
• Change control experience; Windchill platform experience preferred.

Responsibilities

• Responsible for executing document control and records management processes and ensuring records are processed, retained and updated appropriately.
• Trains peers on various processes.
• Authors and develops new documents and processes.
• Manages change control processes and meetings to ensure timely processing of change requests.
• Identifies projects to improve department processes.

Skills

MS Office & SharePoint

Writing & Editing

Attention to detail

Organizational skills

Communication

Team collaboration

Problem solving

Change control

Process development

Education

BS/BA in engineering, business, life sciences or similar

Tools

Windchill

Job description

Zimmer Biomet seeks a document control specialist to manage records and ensure compliant documentation. You will train peers, author new documents, and lead change control activities to support timely processing of requests.

Ideal candidates have 1–3 years in QA/compliance within medical devices, knowledge of 21CFR 11/820 and ISO 13485, and experience with eDM systems; Windchill experience is a plus. Hybrid on-site work in WARSAW IN preferred.