Apex Systems, Inc.
Develop and update Manufacturing procedures, QC procedures, and other documents from a Device Master Record (DMR)
Manage document change control
Regularly interact with subject matter experts and attend project team meetings
Manage documentation review and approval: Proactively solicit and rapidly incorporate feedback from other functions (QA, RA, R&D, MFG, etc).
Maintain integrity of documents to comply with and be incorporated into the company’s quality procedures. High quality, well formatted, clear documentation following GDP (good documentation practices) is mandatory.
Work with minimal supervision and manage time effectively
Deliver under tight deadlines
Identify and communicate risks to project deadlines in advance
Adapt to changes in project priorities
Any other duties as required for the role
M.S. degree in a life science (biomedical) or quality field.
A minimum of 3 years of experience supporting IVD products, including writing Design Control documentation and DMR documentation.
Experience in Molecular Diagnostics preferred
Advanced knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook, etc.).
Strong experience in Design Control, ISO 13485, and 21 CFR Part 820 Quality Systems Regulation.
Quick learner, thorough understanding of presented technical/scientific content.
Ability to write clearly, concisely, accurately, and quickly under tight deadlines.
Keen attention to detail and high regard for quality.
Experience working in a self-driven, performance/results oriented, fast paced matrixed environment.
Willingness to take on new challenges.
Able to adapt to changing needs caused by time, budget, or other constraints.
Excellent problem solving skills, including issue resolution.
Must be highly collaborative; Have the ability to work within a diverse team and contribute to a supportive, positive work environment both within the team and in the greater community
VEVRAA Federal Contractor
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.
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Apex Systems, Inc.
Website : http://www.apexsystemsinc.com