Lead document controller

job summary :

A Lead Document Controller for a medical devices and equipment manufacturing company is needed in the Kalamazoo, MI area. This role is focused on managing the compliant release and lifecycle of medical device documentation within a PLM system, ensuring all records meet strict global regulatory standards.

location : Kalamazoo, Michigan

job type : Contract

salary : $33.16 - 46.43 per hour

work hours : 8am to 5pm

education : Bachelors

responsibilities :

• Manage the end-to-end lifecycle of documentation, including control, review, release, archiving, and obsolescence of procedures and specifications.
• Coordinate document routing and distribution to ensure the latest effective versions are accessible across company sites.
• Provide Subject Matter Expert (SME) guidance on document control processes and Product Lifecycle Management (PLM) system navigation.
• Execute post-release tasks and support periodic document reviews to ensure alignment with ISO 13485, MDSAP, and FDA 21 CFR Part 820.
• Deliver coaching, training, and support clinics to cross-functional teams on change processes and documentation standards.
• Facilitate the implementation of external corporate documents into the local Quality Management System (QMS) via the CIDT process.
• Retrieve documentation and data promptly to support investigations, regulatory audits, and reporting requirements.
• Participate in issue investigations, root cause analysis, and the implementation of corrective actions and process improvements.
• Serve as the primary point of contact for process owners and act as a backup to the Change Specialist.

Skills :

Ability to gain knowledge and understanding of US and International Medical Device Regulations (ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations desired).

Ability to gain knowledge of supporting Quality Systems (e.g. Audits, Management review, Quality Planning).

Ability to demonstrate basic communication, identify problems, recognizes areas for improvement and contribute to data management and training

Ability to follow instructions, complete task with supervision, identify urgent task and address immediate conflicts

Understands basic regulatory concepts, recognizes industry standards and can identifies key regulations.

Understands basic communication principles, understands the importance of their input and participates in group discussions.

Education and Experience :

Bachelor's Degree or equivalent.

Minimum of 4 years in a Quality / Regulatory Affairs environment with 2 years experience in Document Control or other related function or 0-1 year experience in a Quality / Regulatory Affairs environment.

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qualifications :

Experience level : Experienced

Education : Bachelors

skills :

Quality

Regulatory Affairs / Compliance

Equal Opportunity Employer : Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including : medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.