We are proud of making a difference over the years through ourpeople, process, product, and innovation. If you thrive in an environment where you can create, implement, anddrive results we want to hear from you! We areactively seeking Quality Assurance Specialistto join our team located inDedham, MA.
Under the direction of the Director of Regulatory Affairs, theprimary responsibilities are to conduct daily quality assurance activities,including quality oversight and auditing of production and incoming inspectionactivities, review and approval of change requests, and investigation ofnon-conformances and out of specification reports. In addition, assist in thedaily activities of Document Control
KEYDUTIES & RESPONSIBILITIES:
- 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 Regulatory Affairs in assuring the quality system is established, implemented, and maintained in accordance to: QSR, ISO 9001, ISO 13485, GMP and MDD. Support 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.
- 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'sdegree in Science or Engineering discipline
- Minimum one-yearwork experience in a relevant manufacturing environment or GMP/ISO operation,e.g., Medical Device and/or Pharmaceutical industries or analytical testinglaboratories is preferred.
- Proficient inMicrosoft Excel and Word a plus
- Good writtenand verbal communication skills; high attention to detail is required
- Create andsupport effective teams
- Capable ofbalancing multiple priorities
- Knowledge ofGMP regulations preferred
AliMedis an Equal Opportunity/Affirmative Action employer. We celebrate a diverse and inclusive workplace.AliMed, participates in E-verify and provides the Social SecurityAdministration (SSA) and Department of Homeland Security (DHS) with informationfrom each new employee's form I-9 to confirm work authorization.