QA Engineer
JOB SUMMARY The QA Engineer will participate in the design, creation, implementation and monitoring of programs and methodologies to ensure that assigned Luminex products meet established specifications, design criteria and control, quality and regulatory standards and customer requirements. QA Engineer provides sustaining and design control quality support for on-market products and products under development. QA Engineer develops and provides leadership for Quality System processes. Key Responsibilities and Duties Evaluate deviations, non-conformances, customer complaints and process/product change control for completeness and impact on quality for on-market products Review, consult and approve Risk Analysis Serve as Quality representative on product development teams responsible for Design Control requirements Provide leadership and guidance for developing equipment/product/process Verification & Validation Protocols Review records for product release and documents for completeness & accuracy under a production schedule Identify key performance metrics and develops reporting mechanism Prepare and presents material at meeting Identify, investigate and collaborate with other departments to resolve quality issues Lead continuous improvement opportunities and works cross-functionally to implement corrective/preventive actions Support Quality system training and participates in the development of training programs regarding all aspects of producing quality products Serve as a resource within and cross departmental for quality related questions & challenges Support audits and inspections Support and participate in other QA related activities as required Other duties as assigned Additional Responsibilities and Duties QUALIFICATIONS Education Bachelor's Degree required with a life science or engineering discipline Required Work Experience Experience in a Quality Assurance, Engineering, or Scientist role Required 5
Years Experience with change control & complex problem solving Required 3
Years Knowledge of cGMP regulations (21 CFR 820, ISO 13485) Preferred Specific Licenses and Certifications Certification in a quality discipline preferred, such as CQM, CQA, CQE Preferred Training and Skills Knowledge of cGMP regulations (21 CFR 820, ISO 13485) preferred Certification in a quality discipline preferred, such as CQM, CQA, CQE Computer skills (Microsoft Windows and Office programs), familiarity with Oracle, preferred Demonstrated problem-solving and analytical skills Verbal and written communication skills High Organizational and time-management skills High PHYSICAL DEMANDS AND WORKING ENVIRONMENT The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical Demands Must work onsite at Luminex office at least 90% of the time Work is normally performed in a typical office work environment Possible exposure to mechanical, biologic and chemical hazards Frequent use of personal computer, copiers, printers, and telephones Frequent work under stress, as a team member, and in direct contact with others Travel Requirements Estimated Amount Brief Description 10% Travel may be required Luminex Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability status of an otherwise qualified individual, citizenship status, membership or application for membership in a uniformed service, or any other protected characteristic or category protected by applicable law.
Salary Range:
$80K -- $100K
Minimum Qualification
Systems Architecture & Engineering, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Years Experience with change control & complex problem solving Required 3
Years Knowledge of cGMP regulations (21 CFR 820, ISO 13485) Preferred Specific Licenses and Certifications Certification in a quality discipline preferred, such as CQM, CQA, CQE Preferred Training and Skills Knowledge of cGMP regulations (21 CFR 820, ISO 13485) preferred Certification in a quality discipline preferred, such as CQM, CQA, CQE Computer skills (Microsoft Windows and Office programs), familiarity with Oracle, preferred Demonstrated problem-solving and analytical skills Verbal and written communication skills High Organizational and time-management skills High PHYSICAL DEMANDS AND WORKING ENVIRONMENT The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical Demands Must work onsite at Luminex office at least 90% of the time Work is normally performed in a typical office work environment Possible exposure to mechanical, biologic and chemical hazards Frequent use of personal computer, copiers, printers, and telephones Frequent work under stress, as a team member, and in direct contact with others Travel Requirements Estimated Amount Brief Description 10% Travel may be required Luminex Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability status of an otherwise qualified individual, citizenship status, membership or application for membership in a uniformed service, or any other protected characteristic or category protected by applicable law.
Salary Range:
$80K -- $100K
Minimum Qualification
Systems Architecture & Engineering, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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