ICONMA, LLC Design Quality Engineer in Westford, Massachusetts
Develop incoming inspection processes and document incoming inspection activities.
Provide in-process QA support to include inspection and document review.
Complete final acceptance activities.
Manage the sterilization process, including validations and product sterile loads.
Track nonconforming material and lead Material Review Board (MRB) efforts. Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
Lead complaint investigations on returned product. Manage corrective action and quality improvement activities.
Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor, and evaluate quality system metrics.
Responsible for creating risk analyses and FMEAs. Responsible for conducting design verification and Design validation activities.
Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
Develops product quality plans, documents, and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.
Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.
BS Degree with minimum 2 years related experience is required.
BS in Biomedical, Mechanical or Electrical Engineering or related science-based discipline
Experience with Design Verification and Validation planning & execution.
Experience with Risk Management activities is required.
Experience with updating FMEA documents.
Experience with design control is required.
Experience with Medical device standards IEC 60601, ISO 14971 is preferred.
As an equal opportunity employer, ICONMA prides itself on creating an employment environment that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual orientation, citizenship, or disability.