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Engineer, Sr. Quality N02
Ref No.: 18-13200
Location: Southborough, Massachusetts
Sunrise System Inc. is currently looking for Quality Engineer in Southborough, MA with one of our top client.
Job Title: Quality Engineer
Job Id: 18-13200
Location: Southborough, MA 01772
Duration: 8 months
Position Type: Hourly contract Position (W2 only)
  • 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.
  • Provides 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 
  • Bachelor’s degree in Engineering discipline or equivalent.
  • Eight plus years related experience and/or training; preferably in the medical device industry related to process/quality engineering.
  • Leadership experience (i.e. People and Administrative Skills); ability to lead and manage cross-functional teams.
  • Knowledge of basic mechanical testing and material properties.
  • Knowledge of metrology. Requires background and familiarity with U.S.
  • FDA QSR, requirements including ISO 9001, MDD 93/42, ISO 13485-2003, and Canadian Medical Device requirements.
  • ASQ certifications in one or more of the following areas is preferred but not required: Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA).
  • Working knowledge of problem solving skills good statistical and analytical skills.
  • Working knowledge of Problem Solving Tools (i.e. Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PDCA, Pareto Analysis, etc.)
  • Working knowledge of Quality Tools (i.e. Quality Planning, Quality Costs and Assessment, Basic Statistics, Advance Statistical Techniques, Technical Writing, Metrology & Calibration, Inspection and Testing, Sampling Principles and AQL, TQM, Lean, Six Sigma, etc.)
  • Good verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations.
  • middle and upper management Proven Project Management skills.
  • Proficient in the use of Information Technology and applications. 
Praful Prasanna
Email: | Direct: (732) 272 0326
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: