Senior Quality Engineer
Beaver-Visitec International - Waltham, MA

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A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International currently seeks talented professionals to help create and promote innovative, new microsurgical products for ophthalmic surgery.

Responsibilities:

Responsible for:

*Improving the effectiveness of the Quality System

*Supporting engineering and R&D projects

*For leading operational projects, where appropriate

*Continuous improvement activity to reduce process variation, eliminate non-value added activity through the use of six sigma, lean, and validation initiatives

*Preparing and/or reviewing/approving validation protocols and reports, FMEA’s, risk analyses, standard operating procedures, manufacturing and inspection procedures, bill of materials, routings, inspection plans, drawings, and purchase specifications

Responsible for supporting operational/QA activities, such as complaint handling, non-conforming material disposition, corrective and preventive actions, internal and external audits, and calibration

Supervisory responsibility of inspectors and technicians may be required

Qualifications:
  • Required Skills and Knowledge - BS Degree in Science or Engineering. Must have in-depth knowledge of proven problem solving techniques such as: lean, DOE’s, statistical analysis, TQM methods, Six Sigma methodology. Proven ability to support and lead teams and cross train other associates.
  • Technical Area of Expertise - 5 or more years experience in the Quality Assurance Profession or related position; knowledge of manufacturing process; 2 years experience with FDA QSR, ISO9000 or ISO13485 compliance desirable; additionally, individual 1-2 years supervisory experience preferable
Demonstate:

Process Validation experience (IQ, OQ, and PQ)

Understanding of Process Capability, Cpk

Problem solving skills utilizing six sigma, 5 Whys, 8D

Investigation and corrective action of Nonconformances and customer complaints

Good written and oral communication skills

Beaver-Visitec International - 18 months ago - save job - block
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