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Quality Engineer
Ref No.: 19-09893
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: 19-09893
Location: Southborough, MA 01772
Duration: 5 months
Position Type: Hourly contract Position (W2 only)
 
Responsibilities
  • Cross-Functional Team member to support, procurement, manufacturing and servicing processes representing Supplier Quality Engineering discipline.
  • Completes assigned Supplier Quality Engineering tasks to schedule.
  • Promotes awareness of Quality and Regulatory Requirements 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 compliance and maintenance of standards (e.g., FDA, ISO13485) and OSTA Quality policies and procedures.
  • Applies the requirements of the Quality System to processes, products or services for multiple remote locations.
  • Supports the manufacturing line to address quality issues and resolution.
  • Using Non-conforming material reports(Client) and/or supplier corrective action requests(SCAR).
  • Supports validation and verification strategy for changes to existing products and processes as assigned.
  • 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.
  • Participates 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 labeling, 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
Qualifications
  • Bachelor's degree in Engineering discipline or equivalent.
  • Eight plus year's 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 13485-2016, 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 to management.
  • Proficient in the use of Information Technology and applications. 
Contact
Abdul. A
Direct: (732) 272 0298 | Email: Abdul.A@sunrisesys.com
Or
Michael Peng
Direct: (732) 272 0265 | Michael@sunrisesys.com