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Description:
The Quality Ops Analyst is responsible for day-to-day administration of the Quality Assurance programs in support of the company's Quality Management System. The Quality Ops Analyst will be involved in the development, implementation and maintenance of Quality System processes to meet the requirements of US FDA (e.g., 21CFR 820 QSR), ISO 13485), and other applicable quality and regulatory standards. The Quality Ops Analyst works with relevant departments to ensure successful implementation of quality systems and communicates the impact of changes to areas affected to ensure that the changes are integrated into day to day operations. The Quality Ops Analyst I coordinates and participates in internal audit activities and key quality initiatives as appropriate. The Quality Ops Analyst recommends CAPAs and SCARs based on top issues seen from NC activities and supports the compilation of device master records, device history records, training records, CAPA records and other Quality System records.
Key Responsibilities - Develop and improve procedures - Administer and maintain training records and other Quality System records for the Quality System department. - Identifies quality improvement in areas of responsibility. - Support review and maintenance of manufacturing Device History Record (DHR). Perform instrument release activities. - Drives timely resolution of deviations related to DHRs, disposition of and escalates in case of delays. - Support manufacturing in rework. Ensure rework activities are adequately documented and risk impact outlined. - Assist in training in GDP and other relevant Quality System training. - Support the equipment calibration system by conducting periodic audits to ensure equipment used in manufacturing is within the allowable calibration date, generating reports as required of upcoming calibration due and assisting in the overall calibration equipment program. - Support and preventive maintenance program - Support Quality system audit activities - Prepare and quality reports, data, and key performance indicators for management reviews. - Ensure proper handling, quarantine and disposition of discrepant material - Identify top issues and recommend CAPAs/SCARs and drive to closure where required. - Conduct failure investigations associated with complaints as required. - Other such duties as determined by Manager. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Additional Skills & Qualifications:
Minimum Requirements - Bachelor's Degree - Quality or Compliance related experience in IVD, Medical Device, or Biotechnology organization
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
