Quality Engineer

Job Locations US-PA-Bethlehem
ID
2020-1204
Category
Other
Type
Regular Full-Time

Overview

Quality Engineer participates and supports activities in the Quality Assurance Department that ensure all goods manufactured and services provided by the Company meet the quality requirements of the Company, regulatory and notified bodies.

Responsibilities

  • Evaluate Non Conformances, Customer Complaints, CAPAs. Identify corrective and preventive action; determine assignable root cause, complete failure investigations and follow up to corrective and preventive actions, ensuring adequate and timely closure.
  • Write and maintain procedures/processes relating to the Quality Management System.
  • Prepare and present quality reports, data and Key Performance Indicators to management for review.
  • Review/document Change Control Requests, ensuring compliance with cGMP and quality standard requirements. Follow-up on recommended actions.
  • Implement Key Performance Indicators. Review and monitor trends, communicating out-of-norm issues to department management. Contribute to and assist in providing quality system training Company wide.
  • Assist in ensuring departmental understanding and compliance with the requirements of cGMP as applied to the company's products and processes.
  • As needed, assist in providing training and support to other departments.
  • If assigned, manage and facilitate the complaint process. Perform and/or facilitate data collection/entry, investigation, closure, customer communication, and file storage for customer complaints.
  • If assigned, support regulatory compliance of the complaint system, including Medical Device Reporting, field action and other regulatory reporting as necessary.
  • Initiate improvements to the Quality management system, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
  • Implement Key Performance Indicators. Review and monitor trends, communicating out-of-norm issues to department management. Contribute to and assist in providing quality system training Company wide.
  • Lead/participate in and support internal and external audit program, and/or other audits as needed. Ensure timely, accurate completion of audits.
  • Participate in the development, and maintenance of the Company's Quality System to meet the requirements of US FDA, 21CFR 820 QSR, 21 CFR 600 and 21 CFR 211 , IS09001 , EN46001, IS013485:2016, MDSAP, WHO and all other applicable quality and regulatory standards.
  • If assigned, support execution of quality processes such as Quality Board investigations, Recall execution, ownership of NCR and CAPA investigations, support of quality information systems to include document control, electronic batch records, NCR, CAPA, complaint handling software, calibration program.
  • Apply risk-based approach to the execution of the quality system (Understand business continuity, resiliency, prioritization, contingency planning and ability to use risk management tools).
  • Provide recommendations on adequate testing and inspection procedures, sampling and sample sizes for production processes, studies and investigations when required.
  • Support other departmental activities as requested by department management or designate.

Qualifications

  • Demonstrated knowledge of Quality Management Systems.
  • Experience with internal and external audit processes (leading & performing).
  • Demonstrated knowledge of cGMPs, FDA regulations, and SO P's.
  • Demonstrated advanced computer skills - Microsoft Office preferred.
  • Excellent verbal, written and interpersonal skills, including the ability to conduct verbal presentations appropriate to the level of the audience.
  • Demonstrated success working in a team environment.
  • Ability to travel by car and/or plane, up to 10%. Additional travel may be required based on business need.
  • Direct experience with statistical techniques and associated software.
  • Lean Six Sigma Green/Black belt desired.
  • Certified Quality Auditor and/or Certified Quality Engineer desired.
  • Bachelors/Undergraduate Degree in quality or science discipline (chemistry, biology, microbiology or medical technology preferred) or Associates degree with minimum of 7 years’ experience in a quality assurance/quality control discipline. Advanced degree/certifications desired.
  • Minimum of five (5) years progressively responsible experience in a drug manufacturing, medical device, or biologics industry in a direct Quality Assurance or Quality Engineering position.
  • Ability to view video display terminal images for extended periods of time - up to four (4) hours at a time.
  • Ability to operate a computer keyboard and calculator.
  • Ability to lift, tug, or pull up to fifty (50) pounds.
  • Ability to sit for extended periods of time - up to four (4) hours at a time.
  • Occupational exposure to blood borne pathogens.

 

OraSure Technologies is an Equal Opportunity Employer
EOE/AA

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