Job Title
Document Management Specialist
Location
Warsaw, IN; Raynham, MA; West Chester, PA; Leeds, UK; Cork, Ireland. Hybrid role available within the United States.
Company Overview
DePuy Synthes, part of Johnson & Johnson Medical Devices Companies, specializes in orthopedics solutions across joint reconstruction, trauma, spinal surgery, and sports medicine.
Position Overview
The Document Management Specialist will execute change control processes for Device Master Records, Quality System Record data, and related documents within the PLM system (Windchill). The role supports internal customers, audits, and quality events.
Responsibilities
Execute change control processes related to DePuy Synthes changes, ensuring compliance with procedures.
Select or verify approvers of changes per procedures.
Collect and report metrics pertaining to change control activities.
Communicate the status of changes.
Manage small projects that support departmental objectives and collaborate with other departments or facilities.
Support and recommend improvements to the change control process.
Support internal and external audits and quality events related to change control.
Ensure all activities comply with the documented quality system and current regulatory requirements.
Required Qualifications
University/Bachelor’s Degree (or equivalent 4‑year degree) and a minimum of 1 year electronic change‑control experience in a regulated industry (medical device or pharmaceutical preferred).
OR Associate Degree (or equivalent 2‑year degree) and a minimum of 3 years business experience, including a minimum of 2 years with electronic change‑control experience in the medical device or pharmaceutical industry.
OR a minimum of 5 years of business experience, including a minimum of 4 years with electronic change‑control experience in the medical device or pharmaceutical industry.
Strict attention to detail and ability to work in an open office environment and remotely with virtual teams.
Ability to organize, prioritize, and handle multiple projects simultaneously.
Ability to work independently and prioritize with little supervision.
Strong written and verbal communication and teamwork skills.
Proficient in Microsoft Outlook, Word, Excel, and PowerPoint.
Preferred Qualifications
Proficiency in change control processes and Product Lifecycle Management (PLM) systems, with experience in Agile e6, ADAPTIV (Enovia platform), and/or Windchill PLM applications.
Travel
Up to 10% domestic and international travel may be required.
Compensation
Base pay range: $54,000.00 – $87,400.00 per year.
Benefits
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
Holiday pay, including floating holidays – 13 days per calendar year
Work, personal, and family time – up to 40 hours per calendar year
Parental leave – 480 hours within one year of birth/adoption/foster care of a child
Bereavement leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver leave – 80 hours in a 52‑week rolling period
Volunteer leave – 32 hours per calendar year
Military spouse time‑off – 80 hours per calendar year
Additional benefits available through the company’s benefits program.
Equal Opportunity Employer
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by law. The company actively seeks qualified veterans and individuals with disabilities.
Accommodation Statement
If you have a disability and would like to request an accommodation, please contact the Employee Health Support Center at ra-employeehealthsup@its.jnj.com or use the company's accommodation resources.
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