Document Control Associate - Fort Myers, United States - Merits Health Products

Merits Health Products

Verified Company

Fort Myers, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Merits Health Products is driven to improve lives - every day, all over the world - by making high-quality power mobility chairs and scooters, manual chairs, motorized beds, patient aids, and Stairlifts. Our first-rate designs are the culmination of years of experience and research, as well as a thorough understanding of the special needs of our customers. Merits is synonymous with innovative engineering, constant product development, adaptability, and caring customer support.**
We are currently seeking a _Document Control Associate_
to fill a pivotal role within our growing organization. This is a full-time position based out of our Fort Myers, FL, USA Corporate HQ. This position is tasked with developing efficient processes and procedures and will lead the implementation and management of a successful Document Control and Change System. This role is the primary gatekeeper for all Controlled Documents and will also ensure processes and protocols are followed and communicated throughout the organization.**
Come join our dynamic team of professionals and help us continue to enable independence and accessibility to all, by providing life enhancing quality solutions that support people in living their life to the fullest.

We offer a competitive salary with a full benefits package including health, dental, and vision insurance, supplemental plan options, 401K + company match, generous PTO and paid Holidays, and regular Employee Recognition Luncheons.

ESSENTIAL JOB DUTIES & RESPONSIBILITIES

Collaborate with crossfunctional teams both internally and externally to lead the design, implementation, and review of successful Document Control and Version Control procedures and workflows.
Work closely with engineering teams to understand document requirements and standards.
Establish and maintain a centralized document repository for all company documents.
Create, update, and/or archive controlled documents as needed or as requested for all products and/or services.
Implement version control processes to track and document changes.
Manage and track document versions and revisions to ensure accuracy, traceability, and consistency throughout the organization.
Ensure Document Control processes are followed and that organizational documents are properly maintained and updated as needed.
Alert and/or train specific departments/teams when document additions, updates, or archives are created, pending, completed, or archived.
Provide training for proper document control processes during new hire onboarding and as needed.
Maintain Good Documentation Practices.
Conduct thorough reviews of documents generated by interdepartmental leaders, ensuring accuracy, completeness, consistency, and compliance with established standards, and provide feedback on necessary adjustments as needed.
Plan and prepare for internal, external, and regulatory agency audits and provide feedback to senior leadership of current status.
Stay abreast with cGDP and applicable document storage and access compliance and guidelines.
Follow company safety policies and participate in Safety Training as required and applicable to the position.
Other duties as assigned.

COMPETENCIES & QUALIFICATIONS:

Highly proficient in MS Office Suite and ERP systems.
Experience in an FDA cGMP and/or knowledge of ISO900
Successful record for being the gatekeeper of managing an organization's forms and data in accordance with legal and/or organizational guidelines.
Ability to support multiple projects.
Appreciation of methodologies such as TPS, Six Sigma and/or Lean.
Technically and mechanically savvy with troubleshooting skills to match.
Excellent organization and decisionmaking skills with the ability to meet strict deadlines.
Able to prioritize workload and must be a selfstarting initiative taker.
Must be able to work independently or within a team.
Exceptionally strong written and verbal communication skills.
Must have an employment record free of any serious infarctions within the past 36months, including, but not limited to, a history without limitations which may cause/may have caused safety concerns, issues, incidents and/or accidents.
Must speak, read, and write fluent English.
Must be legally authorized to work in the United States.

Education & Experience Requirements:
Must have a high school diploma or equivalent with a minimum of three (3) years of related experience.

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, stoop, kneel, crouch, climb/climb ladders, or balance; use of hands to handle or feel objects, tools, or controls; reach with hands and arms; frequently required to talk or hear.

Employees must stand for prolonged periods of time during 10-hour work shifts. The employee is required to lift or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance visio