Senior Quality Engineer - AliMed Inc.

Our Company

AliMed is a leading medical products manufacturer and distributor with a vast portfolio of high-quality offerings designed to improve patient outcomes and experiences spanning hospital to home. We remain committed to serving the needs of both patients and providers in the acute, rehab, and post-acute care communities by continuing to build on our strong foundation of innovation, responsiveness, and exceptional customer service that starts with our team of dedicated and talented employees.

As a part of the healthcare industry for over 50 years, AliMed is proud to continue to be able to make a difference through our people, processes, and products. If you would like to be a part of our community and thrive in an environment where you can create, implement, and drive results, we want to hear from you! We are actively seeking a Senior Quality Engineer to join our team located in Dedham, MA.

Essential Duties and Responsibilities:

Primary responsibilities are to conduct daily quality engineering and assurance activities, including quality oversight and auditing of production and incoming inspection activities, review and approval of change requests, and investigation of non-conformances and out of specification reports.

• 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.

Education and/or Work Experience Requirements:

• 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.

Physical Requirements:

• 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.

AliMed is an affirmative action/equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, military service, national origin, age, disability, veteran status, or any other basis protected by applicable state and federal law.