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Quality Engineer

Company:
Lighthouse Placement Services, LLC
Location:
Somersworth, New Hampshire, United States
Posted:
November 09, 2016
Description:

Email resumes to Karyn Liberatore at kliberatore@lighthouseplacement.com.

Jobs open and close rapidly. Please go to lighthouseplacement.com for real time postings.

Quality Engineer

Responsibilities:

Monitoring and improvement of product quality.

Defect, scrap and rework prevention.

Continuous improvement of and adherence to Quality Management System.

Control, document, evaluate and disposition nonconforming materials.

Coordinate and monitor inspection activities.

Investigate, document and communicate customer complaints. Notify QM if event is reportable per Medical Device Vigilance Reporting standards and requirements

Supplier Quality evaluation, monitoring, and improvement.

Review and approve validation activities.

Support Design and Design Transfer activities as needed.

Sterilizations for both ETO and Gamma Radiation in accordance with the appropriate standards.

Ensure adequacy and compliance of Environmentally Controlled Areas.

Provide support for and perform Document Control activities as needed.

Coordinate and perform Corrective Action and Preventive Action activities as required.

Internal auditing as required.

Provide guidance on regulatory requirements.

Perform and/or prepare installation, operational, and performance qualification of equipment as needed.

Provide product specifications and task specific instructions for use by Assembly and Quality, personnel and when required specifying the type of inspection or measuring equipment to be utilized.

Conduct investigations for equipment failing calibration.

Complete, review and approve fixture files as necessary

Assist in maintaining traceability of products.

All other duties as assigned.

Required Skills, Knowledge and Expertise:

Working knowledge of ISO13485, ISO 9001, FDA CFR Part 820, Medical Device Directives

Medical Device Directives and product – specific applicable standards

FDA Quality System Regulations

Canadian Medical Device Regulations

EtO sterilization

Gamma Sterilization

Statistics

Quality Management Tools

Problem Solving

Root Cause Analysis

Supplier Performance

Project Management

Advanced Product Quality Planning (APQP)

Proficient in Microsoft Office Software suite

Desirable Qualifications:

Scientific education (biological sciences or other technical)

Quality Certifications (ASQ or other)

2-5 years Quality/Regulatory experience in medical device manufacturing

Equal Opportunity/Affirmative Action Employer