What are the responsibilities and job description for the Sr. Document Control Specialist position at Noah Medical?
About The Team:
The Sr. Document Control Specialist reports to the Sr. Manager of Quality System Management. This position provides support and ownership to document control processes, training, standards management throughout all stages of product development. We are looking for someone that is highly motivated. The candidate must be a self-starter, team builder, and excellent communicator.
A Day In The Life Of Our Sr. Document Control Specialist:
- Administer document and part workflows within the electronic Product Lifecycle Management (ePLM) system to ensure accurate and timely change orders.
- Track change orders through their lifecycle of creation, routing, approvals, and release.
- Provides training and coaching to the users of an ePLM system.
- Maintain ePLM through executing software validations.
- Participate in document control improvement activities which may include creating and updating SOPs, WIs, forms, and templates.
- Conduct training and manage training programs.
- Notify employees of new or updated training requirements.
- Assist in audits (internal and external).
- Control and manage external standards to ensure US FDA and international requirements are met for design and development deliverables.
- Calculate and report on quality system process metrics.
- Store, maintain, and track records for internal and external storage.
- Other QMS activities as assigned.
About You:
- BA/BS with 6 years of work experience in a regulated industry such as medical device, biopharma, or aerospace, in a document control role or AA/AS with 10 years of work experience in a regulated industry such as medical device, biopharma, or aerospace, in a document control role.
- Experience in medical device quality processes governed by 21CFR820 and ISO 13485 are a plus.
- Excellent time management skills
- Experienced in Microsoft Office, Adobe Reader/Pro, Google Suite and ePLM/eQMS systems and the ability to convert documents within systems.
- Be a self-starter, team builder, excellent in communication skills (written and verbal), detail oriented, organized, and able to prioritize and balance workload in a start-up environment.
- Ability to support multiple cross functional teams in a fast-paced and high-pressure environment.
- Demonstrate solid background of technical knowledge and experience.
Workplace Type: Hybrid
Benefits & Perks (For Full Time Employees):
- Competitive Salary
- Comprehensive health insurance including Medical, Dental and Vision HSA and FSA options
- Equity & Bonus Program
- Life Insurance (company paid & supplemental) and Disability insurance
- Mental health support through medical insurance programs
- Legal and Pet Insurance
- 12 paid holidays, 15-20 days of PTO use-what-you-need sick days
- Paid parental leave
- In-office snacks and beverages
- In-office lunch stipend
- Learning & Development Opportunities: On-demand online training and book reimbursement
- Team building and company organized social and celebration events
#LI-Hybrid
