Quality Assurance Associate
New York , NY 11215
Posted 6 days ago
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Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding.
Please refer to these associated links to learn more about Cresilon:
The Quality Assurance Associate is required to utilize and comply with 21 CFR 820 and ISO 13485 for medical devices, including but not limited to, quality system implementation, document and record control, training, investigations, CAPAs, complaints and post-market activities.
The QA Associate must adopt and maintain a culture of excellence and quality in all aspects of his/her job function. The QA Associate will work in a highly regulated environment and aid in ensuring that the Quality Management System methods and Quality System Regulations are applied throughout Cresilon.
- Participate in maintaining and monitoring FDA QSR 21 CFR 820 and ISO 13485 systems or other recognized regulatory standards for all markets in which our products are sold.
- Establish processes and procedures to ensure compliance and improvement to the Quality Management System (QMS), focusing on the following subsystems:
- Non-conformances and Deviations
- Change Control
- Corrective and Preventive Actions
- Complaint Handling
- Documentation and Record Controls
- Risk Management
- Post Market Surveillance
- Data Integrity
- eQMS Management
- Trend and analyze data to present areas of improvement to executive management.
- Handle aseptic products and quality systems associated with aseptic products manufactured within Grade A to D cleanrooms.
- Interface with all technical departments in a team-based environment to ensure process and product compliance with all relevant quality standards as well as internal policies and procedures. Actively develop, mentor, train and instill a site GMP culture.
- Support QA Management with department strategy development, objectives and goal setting, project prioritization activities.
- Other duties may be assigned as deemed necessary by the supervisor.
- Bachelor's degree in Science, Quality Assurance, Engineering or related scientific discipline.
- 1-2 years experience working with ISO 13485, ISO 14971, 21 CFR 820, 210, 211, cGMPs.
- 1-2 years experience working with document, record and training control.
- 1-2 years experience working with investigations, CAPAs and change management.
- Ability to generate and review protocols and Standard Operating Procedures (SOPs), which comply with internal and external standards.
- Proficient in the use of MS Office.
- Experience with Sharepoint, PowerBI, and other automation tools preferred.
- Strong analytical, written, and communication skills including technical writing.
- Ability to interact with and influence diverse cross-functional teams.
- Experience taking initiative to solve problems with innovative ways in a fast-paced, and changing business environment.
- Detail oriented, proactive, results driven, decisive, and responsive.
BenefitsPaid Vacation and Holidays (Minimum of 25 paid vacation days)Medical, Dental, and Vision InsuranceFirm Paid Life and Short-Term Disability Coverage401(k) Retirement Savings Plan with Company MatchMonthly MetroCardStock Options