Document Control Assoc Specialist

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

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

Responsible for executing document control and records management processes and for ensuring records are processed retained and updated appropriately.

How You'll Create Impact

Trains peers on various processes

Authors and develops new documents and processes

Manages change control processes and meetings with TMs to ensure timely processing of change requests.

Identifies projects to improve department processes

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

What Makes You Stand Out

• Action oriented, drives for and achieves results.
• Must be proficient in MS Office and Sharepoint.
• Strong bias for coaching and mentoring others. This includes ability to effectively train team members within a class-room or workshop setting.
• Proven strong writing and editing skills.
• Proven excellent attention to detail and proofreading skills.
• Strong organizational skills and the ability to multi-task.
• Strong and effective communicator (written and verbal).
• Motivated and proven ability to work in a team-oriented, global environment, including interacting effectively with all levels and outside contacts.
• Excellent problem identification and solving skills.
• Sound decision making skills, solid under pressure.
• Effective process development and process management skills.

Your Background

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

Travel Expectations

up to 15%

Hybrid mode 3 days on-site in WARSAW IN.

Salary Expectations

$51,000-$63,000 USD

EOE/M/F/Vet/Disability