Quality Assurance Operations Specialist
New York , NY 11215
Posted 1 week 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 QA Operations Specialist is responsible for maintaining, coordinating activities and implementing improvements for systems, controls and personnel associated with Incoming, In Process and Finished Goods Quality inspection and/or testing and Manufacturing Operations. They must adopt and maintain a culture of excellence and quality in all aspects of their job function. They are required to assure compliance with regulations and promote good manufacturing and/or good product quality engineering practices.
- Ensure compliance and improve the Quality Management System (QMS) pertaining to manufacturing operations and product lifecycle.
- Work with aseptic products in a sterile environment including ISO 5/Grade A cleanrooms.
- Review batch records and test reports timely for release of product.
- Ensure and maintain full traceability for all batches manufactured.
- Ensure the overall systems, processes, standard operation procedures (SOPs), production lines, equipment, facilities are adequate for manufacturing compliant products.
- Maintain quality standards and procedures for processing materials into partially finished or finished material or product as well as, machining, inspection, receiving inspection raw and semi-finished product, labelling, cleaning, packaging, labelling, including partnership of validation, calibration and metrology activities.
- Inspect and release product line for production and monitor line clearance post-production.
- Define production and inspection methods using applicable industry standards (USP, ISO, AAMI, ASTM, and IEC) and monitor performance in accordance.
- Conduct quality inspections for incoming, in process and finished goods including using lab instruments and equipment.
- Determine the need for change control and establish and maintain change control requests.
- Capture and address observations and non-conformances in a timely manner.
- Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans.
- Establish, monitor, track and trend quality indicators. Conduct internal audits.
- Timely report compliance and trending issues to QA Management.
- 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.
- Interface with Manufacturing Operations, Quality Control and Engineering departments in a team-based environment to ensure process and product compliance with all relevant quality standards, including qualification of personnel to perform quality activities.
- Actively develop, mentor, train and instill a site GMP culture.
- Identify training needs and organize training interventions to meet quality standards.
- 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.
- 5-8 years experience working in Quality Assurance / Quality Control in a medical device / pharmaceutical manufacturing environment.
- 5-8 years experience working with ISO 13485, ISO 14971, ISO 14644, 21 CFR 820, 210, 211, cGMPs.
- Experience handling aseptic products / working in cleanrooms.
- Bachelor's degree in Science, Quality Assurance, Engineering or related scientific discipline.
- Experience with pharmaceutical and medical device test standards (USP, ISO, AAMI, ASTM, and IEC).
- Understanding of ISO 13485 and FDA 21 CFR 820.
- Ability to generate and maintain protocols, Design History Files (DHF) and Standard Operating Procedures (SOPs), which comply with internal and external standards.
- Proficient in the use of MS Office.
- Lean Six Sigma Certification preferred.
- Experience with Sharepoint, PowerBI, and other automation tools preferred.
- Strong analytical, written, and communication skills including technical writing.
- Ability to take initiative to solve problems in a fast-paced and changing business environment.
- Ability to meet deadlines and deliver work timely.
- Detail oriented and possesses organizational skills.
- Proactive, results driven, decisive, and responsive.
- Ability to handle a wide set of responsibilities and wear multiple hats.
- Ability to interact with and influence diverse cross-functional teams.
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