Quality Assurance Specialist
18 hours ago
Abbott Laboratories is seeking a highly skilled Quality Assurance Specialist to join our Structural Heart Division team in Santa Clara, CA. As a key member of our team, you will be responsible for conducting functional testing, receiving inspection activities, and ensuring the quality of our medical devices.
Key Responsibilities- Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions.
- Responsible for receiving inspection activities including but not limited to inspection and gathering all defined requirements and documentation to release parts/components.
- Responsible for the inspection of components/materials, information for use (IFUs), packaging, and labeling materials.
- Responsible for performing in-process and final components, sub-assembly and product inspection.
- Measure component dimensions per requirements or inspection plans.
- Understand the capability of measuring tools. Utilize small hand-tools, calibrated instruments, measuring equipment, microscopes and test fixtures.
- Understand engineering drawings and inspection requirements of components and parts.
- Review material product specifications to understand the requirements of the components and parts.
- Document non-conformance report once parts fail specifications or requirements.
- Read and understand certification of conformance and certification of analysis.
- Responsible for Inventory Control including material transfer activities, maintain inventory and inventory logs.
- Records inspection and test data as prescribed by written instructions and procedures.
- Support Equipment Controls and calibration/PM activities including coordination with Calibration house, update Equipment log.
- Work may require collaboration with other Abbott divisions.
- Recommend improvements to the production process to ensure quality control.
- Responsible for completing documentation in a timely manner and in accordance with business standards.
- Foster the production team about quality control concerns to improve quality of the product.
- Maintain quality documentation in accordance with SOPs, WIs and GMP (CFRs).
- Resolve quality-related issues in a timely manner.
- Perform audits of manufacturing records during assembly to ensure compliance.
- Perform final manufacturing Device History Record (DHR) review at close of manufacturing process and product release.
- Support engineering with other documentation related tasks as required.
- Supports trending process and maintains Quality Records.
- Provide Quality support to key processes and product development/improvement projects.
- Adhere to Good Manufacturing Practices and Good Documentation Practices.
- Possess a basic understanding of the Quality System; including the Subsystems and is familiar with the Quality System Key processes.
- Suggests to manager and implements process improvements within own work that fosters a culture of continuous improvement.
- Support other functional area as needed.
- Keep abreast of the standards that regulate our industry.
- Take appropriate action per procedural requirements and schedule when identify any potential nonconformance.
- Work with engineers and manufacturing to transfer technical information into easy to understand written form, as well as take a hands-on approach to learning and documenting the processes.
- Ensure storage of samples and documents in the appropriate filling systems.
- Perform audits of manufacturing records during assembly to ensure compliance.
- Perform final manufacturing Device History Record (DHR) review at close of manufacturing process and product release.
- Support engineering with other documentation related tasks as required.
- Travel up to 10% of the time as necessary to support organizational goals.
- Other tasks and duties as assigned.
- High school diploma or equivalent qualification.
- Excellent knowledge of MS Office and Excel.
- Good math and technical skills.
- Strong understanding of quality control standards and testing techniques.
- Must have a minimum of 5 years experience working in inspection, or related field.
- Positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to maintain regular and predictable attendance.
- Very high level of attention to detail and accuracy.
- Excellent verbal and written communication skills.
- Ability to collaborate effectively.
- Must be an effective team player with the ability to train other technicians.
- Confident and open personality who can communicate effectively, both written and orally with people at all levels.
- Ability to work efficiently under tight timelines.
- 5+ years prior medical device experience preferred.
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