Farmingdale, New York
- Review customer complaints, conduct product investigations, and ensure proper complaint closure
- Conduct medical device reporting assessments and investigations.
- Ideal candidate should possess good problem solving & logical decision-making abilities.
- Develop sampling plans for evaluating, and reporting quality and reliability data.
- Demonstrate continuous effort to improve product quality and manufacturing processes.
- Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
- Provides Quality Assurance leadership for Project Teams or Quality Department.
- Creates, reviews and approves Quality System Documents (ex. CAPA, Audits).
- Creates, reviews and approves Product Documents.
- Creates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols, Software Validation documents.
- Mentors entry point staff.
- Provides supervision to technicians and entry level engineers.
- Assists in the review and interviews of potential candidates.
- Creates, reviews and approves documents required for Design History File.
- Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA.
- Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans.
- Performs Internal or Supplier Quality System Audits.
- Ensures compliance to Department procedures.
- Tracks and trends Quality Indicators.
- Serves as Independent QA Reviewer and Chairperson for Design Reviews.
- Quality Engineering and Customer Complaint Investigation experience
- Working knowledge of standards and regulations, including but not limited to US-FDA’s 21 CFR Part 820 and 21 CFR Part 803, and GMP.
- Medical Device Industry experience and working knowledge of ISO-13485 preferred Quality management systems, and ISO 14971 Medical devices
- Demonstrated good written and oral communication skills
- Proficiency in Microsoft Office package
- Experience in root cause analysis and problem solving techniques
- Knowledge of basic quality tools, risk analysis & statistics
- BS degrees in an engineering/scientific or quality management curriculum.
- A minimum of 5 – 7 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
- Experience in the development and implementation of effective Design Control Systems.
Job ID: 16215