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EG10 - Engineering Manager

Kelly Services eAccounts, Southborough MA

Senior Quality Engineer

3-4 month contract

48.61 - USD 55.56 per hour

Southborough, MA


Responsibilities: 

  • Cross-Functional Team member to support new product development, procurement, manufacturing and servicing processes representing Quality Engineering discipline
  • Completes assigned Quality Engineering tasks to schedule.
  •  Promotes awareness of Quality and Regulatory requirements.
  • Leads or participates in the development of process and procedure development/changes.
  • Applies statistical process control (SPC) methods to evaluate current processes and process changes.
  • Develops new approaches to solve problems identified as part of the team.
  • Assist in the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA Quality policies and procedures.
  • Trains location personnel on all aspects of the Quality System and regulatory standards.
  • Serves as a mentor for the Quality team to assist in developing Quality Engineering skills.
  • Applies the requirements of the Quality System to processes, products or services for the location.
  • Supports the manufacturing line to address quality issues and resolution.
  • Support to metrology and preventive maintenance programs.
  • Supports validation and verification strategy for new and existing products and processes as assigned.
  • Leads the development and maintenance of Master Validation Plans.
  • Participates in the CAPA process as required as an assignee or project team member.
  • Investigates escalated product complaints to root cause to ensure timely customer response and correction.
  • Monitors product and process performance metrics and acts upon trends (positive or negative).
  • Leads MRB as a team member to ensure proper disposition of non-conformances.
  • Authors, collaborates, and approves Quality System documentation including change orders, DHF, DMR, DHR, labels and labelling, etc.
  • Conducts internal, vendor, and process audits to schedule.
  • Interfaces with suppliers to resolve Quality issues
  • Develops and drives measurable Quality improvements relating to products, processes and services.
  • All other essential related duties as required 
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