- Serve as the Document Control reviewer and/or approver, ensuring documents/records and changes comply with established procedures and requirements, and ensuring change elements are identified, compliant, and assembled for review and approval
- Promptly process Document/Engineering Change Requests and Change Orders (DCR, DCO, ECR, ECO) in compliance with Document and Record Control processes
- Ensure appropriate functional area representatives are involved in review and/or approval
- Process and archive paper and electronic quality records; review for compliance to applicable standards
- Implement employee training on documents, SOPs, and procedures
- Track, manage and report training compliance on continuous basis
- Coordinate new hire onboarding processes as related to the QMS
- Deliver change control data, reports, and information upon request
- Deliver Regulatory submission requests for documentation upon request
- Assist in projects for continuous improvement of the eQMS
- Bachelor's degree
- Minimum two years of relevant experience, preferably in a Quality function in the Medical Device or regulated industry
- Organized, self-motivated, ability to effectively manage multiple projects and priorities; high attention to detail
- Effective interpersonal and communication and writing skills
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Document Control Specialist - Alameda, United States - iota Biosciences, Inc.
Description
We are looking for a Document Control Specialist who is highly motivated and passionate to manage quality system and product supporting documentation for novel Class III active implantable devices.
The Document Control Specialist will be expected to:
iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company pioneering bioelectronic solutions across a range of medical therapies and diagnostics.
Bioelectronic medical implants are the start of an entirely new form of medicine, treating chronic diseases through non-pharmaceutical mechanisms not previously accessible to clinicians.
iota Biosciences, Inc. was acquired by Astellas Pharma US in November 2020. Astellas Pharma US, Inc. is an affiliate of Tokyo-based Astellas Pharma Inc., a top 20 global pharmaceutical research company.Astellas is committed to turning innovative science into medical solutions that bring value and hope to patients and their families.
iota's core proprietary technology stack leverages ultrasonic energy to communicate with and power custom implantable devices, enabling completely new clinical approaches to treating diseases.
At iota Biosciences you will be given the opportunity to substantially influence the design and success of these pioneering Class III medical implants, as the company expands the reach of its novel technology while bringing new solutions to the clinic.
At iota Biosciences, we take pride in providing equal employment opportunities to everyone, inclusive of race, ethnicity, beliefs, religion, marital status, gender, gender identity, citizenship status, age, veteran status or disability.
iota offers a very competitive benefits package that includes the following:Health & Wellness
Comprehensive health coverage for you and your family, covered at 100%
Access to quality dental and vision
Onsite Gym in Alameda
Work-Life Balance
Generous vacation pay
Paid parental leave
Options for flexible work schedules
Competitive Compensation
Annual Bonus Plan
Long Term Incentive Plan (LTIP)
401k plan with employer match
