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Sr. Document Control Specialist
Noah MedicalSan Jose, United Statesfull_timeVerifiedPosted 28 Nov 2023
About the role
Who We Are
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple disease states. Based in Silicon Valley and backed by well-known institutional investors, our incredibly talented team of engineers, innovators and industry leaders brings years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics & Hansen.
The Sr. Document Control Specialist reports to the Director, Quality Assurance and Management Rep. 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.
• 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
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
Please visit our Careers Page to view our latest openings.
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple disease states. Based in Silicon Valley and backed by well-known institutional investors, our incredibly talented team of engineers, innovators and industry leaders brings years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics & Hansen.
The Sr. Document Control Specialist reports to the Director, Quality Assurance and Management Rep. 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.
- Update user access and rights within the ePLM system.
- 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 work experience in a regulated industry such as medical device or biopharma, in a document control role or AA/AS with 10+ years work experience in a regulated industry such as medical device or biopharma, 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.
• 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
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
Please visit our Careers Page to view our latest openings.
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