Global Document Control & QMS Specialist

Zimmer Biomet; Braintree (MA); On-site; USD 64,000 - 80,000; Full time

Benefits offered by this job

Competitive total rewards

Wellness incentives

Recognition and performance awards

Job summary

Zimmer Biomet, a global medical technology leader, seeks a Document Control professional to manage corporate QMS documentation, including policies and procedures, and to support FDA/ISO compliance.

You will act as eDM administrator, train teams, and coordinate with authors, reviewers, and sites worldwide. Minimum background includes degree and 2+ years′ relevant experience in quality/compliance and knowledge of 21 CFR 11/820; up to 15% travel.

Qualifications

• Bachelor's degree with 2+ years of relevant experience or equivalent.
• BS/BA in engineering, business, life sciences or similar preferred.
• 3+ years in a Quality Control/Quality Assurance/Compliance role within document control in medical devices or life sciences.
• Working knowledge of 21CFR Parts 11 and 820, ISO 13485 QMS.
• Experience with electronic Document Management (eDM) systems.

Responsibilities

• Facilitates the document control process for Corporate QMS documents and related records.
• Collaborates with authors, reviewers and approvers to manage workflow and archiving.
• Performs technical writing reviews of QMS documents for accuracy and compliance.
• Identifies QMS gaps and guides authors to remediate documents.
• Reviews and approves Batch Records and related docs.
• Creates, modifies and obsoletes documents and trains global teams.

Skills

MS Office

SharePoint

Technical writing

Documentation control

Attention to detail

Education

Bachelor's Degree

Associate's Degree

High School Diploma

Tools

eDM systems

Job description

Zimmer Biomet, a global medical technology leader, seeks a Document Control professional to manage corporate QMS documentation, including policies and procedures, and to support FDA/ISO compliance.

You will act as eDM administrator, train teams, and coordinate with authors, reviewers, and sites worldwide. Minimum background includes degree and 2+ years′ relevant experience in quality/compliance and knowledge of 21 CFR 11/820; up to 15% travel.