Quality Assurance Specialist
4 weeks ago
About the Role:
This position is responsible for ensuring the quality and compliance of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories.
Key Responsibilities:
- Lead/support design planning efforts, including heading cross-functional teams and establishing deliverables and tracking completion for complex projects.
- Lead/support complex investigations and corrective and preventative action (CAPA) activities.
- Drive alignment in cross-functional meetings, acting as a QA representative on new and on-market product design projects to ensure compliance with the design control process.
- Review and approve engineering changes in a timely manner.
- Collaborate with R&D and Marketing to support mobile app deployment activities (for Software as a Medical Device projects).
- Drive alignment during cross-functional review and approval of impact assessments, root-cause analysis investigation, and resolution activities.
- Review and approve batch records for products used in design verification/validation testing and clinical investigations.
- Ensure Device History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures.
- Collect, organize, and monitor information related to quality and process improvement.
- Participate in internal & external audits and ensure audit responses are submitted in a timely manner.
Requirements:
- Minimum 5 years applicable technical/engineering experience and demonstrated use of Quality tools/methodologies.
- Minimum 3 years regulated industry experience and preferable experience with design control and software as medical device.
- Preferred Qualifications: Previous experience in completing Field Action packages or understanding of Field Action processes, familiarity with standards and regulations such as ISO 9001/13485, MDSAP, MDR/IVDR, strong and well-developed interpersonal communication skills, continuous improvement methods and application, e.g., Lean, Six Sigma, experience dealing with international locations and businesses.
About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self, and live a full life.
We offer a range of benefits, including career development opportunities, free medical coverage for employees, an excellent retirement savings plan, tuition reimbursement, and education benefits.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
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