Document Control Analyst jobs in Fort Myers, FL

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.

To apply, please read the details below in its entirety and apply with your salary requirements.

ESSENTIAL JOB DUTIES & RESPONSIBILITIES

• Collaborate with cross-functional 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 inter-departmental 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 ISO9001.
• 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 decision-making skills with the ability to meet strict deadlines.
• Ability to consistently and effectively present information and respond in a timely manner to high email/message volume, to questions or inquiries from other employees, managers, and/or vendors.
• Able to prioritize workload and must be a self-starting 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 36-months, 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 vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:  When performing the duties of the job in the production and/or warehousing atmosphere, the employee may need to work near moving mechanical parts where the noise level in this work environment is usually moderate to loud; ambient climate temperatures to occasional humid and hot (depending on season), dry, dusty to moderately clean. Employees may need to work in a cGMP environment requiring additional cGMP attire. The employee may need to don safety equipment/ PPE (Personal Protective Equipment) provided by the company.

When performing the duties of this job in a business office atmosphere, the noise level in this environment is usually quiet to moderate, cool to ambient climate temperatures and moderately clean.

Please feel free to visit our website or our LinkedIn page to learn more about our products, our mission, and our team https://www.meritsusa.com & https://www.linkedin.com/company/merits-health-products-inc./

Please note this job advertisement is not meant to be all inclusive of essential duties and responsibilities. Requirements, qualifications, competencies, tasks, essential responsibilities & duties, physical demands, and work environments which may or may not be reflected in this advertisement, are not exhaustive and may change as determined by the needs of the organization. 

We are an Equal Opportunity Employer, which mean that all applicants will receive consideration for employment without regard to race, color, aga, national origin, religion, sexual orientation, sex (including pregnancy, childbirth, or related medical conditions), gender identity or gender expression, military or veteran status, physical or mental disability, genetic information or any other status protected under application federal, state, and/or local law(s). All employment offers are contingent upon successful completion of a Form I-9, and successful completion of our pre-employment background/criminal checks, and successful completion of a drug screening.