Senior Quality Engineer
AliMed Inc.
- Dedham, MA
- Permanent
- Full-time
- Quality Oversight and Auditing
- Provides quality oversight to production / vendor activities.
- Functions as QA auditor for in-process checks during production and incoming inspection activities.
- Reports findings of in-process audits and provides follow-up to ensure adequate completion of corrective actions.
- Quality Investigations
- Assesses potential impact of proposed changes, and processes non-conformances on the quality and suitability of the product for sale. Performs and coordinates quality investigations with appropriate levels of corrective/preventive actions and closes in a timely manner.
- Supports product quality complaint investigations, assisting in data processing of Adverse Events and appropriate reporting for U.S. and Canada complaints. Supports the receipt/review of product complaint samples. Participates in the investigation and resolution of non-conformances of all types.
- Quality System Maintenance
- Assists the Director of RA/QA in assuring the Quality System is established, implemented, and maintained in accordance with the FDA QSR, ISO 9001, ISO 13485, ISO 14971, GMPs and MDR. Supports initiatives in Continuous Quality Improvement.
- Provides training in GMP and quality principles to personnel in all departments when assigned. Assists in maintenance of training schedules and training records systems.
- Assists in the review and approval of Change Controls.
- Assists in internal and supplier audits and establishing/updating supplier and component specifications and testing as needed.
- Assists with tracking and trending of deviations and complaints.
- Follows all safety rules/regulations and immediately reports infractions and/or workplace injuries/accidents to proper personnel.
- Supplier Quality Management
- Responsible for the maintenance of a Supplier Quality Management Program. Maintains Supplier Performance Rating system. Manages supplier quality issues through monitoring / escalation processes.
- Designs, develops and implements continuous improvement quality management initiatives to improve supplier performance to support manufacturing attainment and customer satisfaction.
- Maintains successful relationships with suppliers, ensures relationship development and management with key Supplier Leadership.
- Provides key Suppliers with technical support, in concert with Sourcing, PD, Engineering and OPS to improve process capacity, quality issue resolution and corrective actions (SCAR oversight).
- Oversees quality system audits, ensuring suppliers followed procedures, employ good manufacturing practices to meet or exceed requirements.
- Analyzes quality data to identify systemic issues and develops supplier specific quality initiative strategies and addresses with key proactive quality tools.
- Document Control
- Coordinates document and data control with the Director of Regulatory Affairs and Document Control Specialist, including creation / review / update of controlled documents and product specification.
- Verifies device finished product. Ensures for product disposition, e.g., approvals for release, distribution or rejection.
- Bachelor's degree in Science or Engineering discipline (equivalent experience may be accepted in lieu of a degree)
- Minimum seven -years of work experience in a relevant manufacturing environment or GMP/ISO operation, e.g., Medical Device and/or Pharmaceutical industries or analytical testing laboratories is preferred.
- Ability to safely and successfully perform the essential job functions consistent with federal, state and local standards, including meeting qualitative and/or quantitative standards.
- Ability to maintain regular, punctual attendance.
- Must be able to lift and carry up to >10 lbs.
- Must be able to talk, listen and speak clearly.