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Quality Engineer

Company:
LanceSoft Inc.
Location:
Acton, Massachusetts, United States
Posted:
April 10, 2019

Description:

Title Quality Engineer

Description

JOB SUMMARY: Primarily manufactures Class I Medical Devices used for patient positioning in the Operating Room. This role has Operations Quality Engineering responsibility to support the production activities for these products.

ESSENTIAL DUTIES AND RESPONSIBILITIES – Other duties may be assigned:

• Serves as the primary point of contact for all operational quality related matters in production.

• Identifies, quantifies, and reports on quality performance metrics and trending analysis for Operational Quality.

• Routinely identify and mitigate product/customer risk and supports complaint investigations.

• Deploy efficient and effective corrections to quality problems in a manner that prevents their reoccurrence using our internal listening systems (ie Internal Audits, NCEs, and CAPAs).

• Manage the ‘Deviation’ process.

• Coordinate NCMR process activities: containment activities for defective parts on the floor, investigate potential impacts / risks of part nonconformities and determine nonconforming part dispositions, attend NCMR Meetings and approve NCMR dispositions.

• Create, edit, approve controlled documents for operations quality processes using document control systems.

• Support manufacturing change control using ECO process. Create, review and approve ECOs as required.

• Review, Revise and approve risk documentation (PFMEA, Risk Plan & Reports)

• Perform periodic review of quality processes used in manufacturing.

• Support Supplier quality management activities. (supplier and part qualifications)

• Coordinate the Ship Hold Process and related documentation.

• Has primary QA responsibility for process validations. SUPERVISORY RESPONSIBILITIES:

• May be responsible for directing some work efforts of QA Technicians.

Skill/ Experience/ Education

Mandatory QUALIFICATIONS:

• The ability to work under the direction of Operations Quality Manager to resolve quality issues in a dynamic environment while managing priorities day to day.

• Quality engineering medical device experience with strengths in Operational Quality

• Knowledge of QSRs, 21 CFR Part 820, ISO 13485, and ISO Quality System Standards

• Excellent analytical & data decision making with sound problem solving skills with experience using root cause analysis tools.

• Ability to partner & communicate well with internal customers, peers, as well as leadership positions.

• Computer literacy skills in applicable programs (MS Office in Windows OS)

EDUCATION AND/OR EXPERIENCE:

• B.S. in Engineering and/or Degree in non-technical field.

• 3-5 years of related medical device / FDA regulated industry quality experience required.

• CQA or CQE desired