- Design and implement audits and control plans for products to ensure product quality targets are met.
- Establish, define, implement, maintain, and report on quality assurance key performance measures and standards.
- Investigate non-conformances and consumer complaints, lead completion of root cause analysis, implement corrective actions, and monitor progress and improvements.
- Drive continuous improvement on quality standards, requirements, and best practices.
- Create and maintain quality systems documentation, such as quality manuals, procedures, and work instructions.
- Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
- Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
- Prepares and presents technical and program information to team members and management.
- Directs technical and administrative workers engaged in quality activities.
- Maintains a working knowledge of government and industry quality codes and standards including ISO 9001 and ISO13485.
- Bachelor of Engineering (BE) or Bachelor of Science in Engineering degree (BSE) or an equivalent number of relevant years of experience.
- Assist in driving continuous improvement on quality standards, requirements, and best practices.
- Experience in CAPA, root cause analysis and 8D.
- Six Sigma Green Belt or Black Belt.
- Demonstrates strong analytical, problem-solving skills.
- Strong written and verbal communication skills.
- Detail oriented, good organizational traits.
- Proficient with word processing software; statistical analysis software (SPC); graphics software; order processing software, and database software.
- Proficient in using Microsoft Office Suite.
- Proficient with precision measurement tools, calibration, and test equipment.
- Master's degree in engineering or Advanced Degree in a related field of study.
- Experience or exposure to the Pharmaceutical/Medical Device Industry with a primary focus on working in a Quality Control / Engineering capacity.
- Experience working in a clean room environment and aseptic manufacturing environment.
- ISO 13485 Internal auditor.
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Quality Engineer - Durham, United States - ILC Dover LP
Description
Job Description
Job DescriptionJob Title: Quality Engineer
Reports to: Site Quality Manager
Job Summary:
The PharmBio business quality engineer actively supports on-site pharmaceutical containment manufacturing on a day-to-day basis. The quality engineer would utilize their knowledge of ILC Dover quality systems to drive compliance to ILC Dover, ISO 9001, ISO 13485, and customer standards. As part of these actions, they will identify continuous improvement opportunities and participate in team activities that drives these opportunities to closure. The quality engineer may also participate in customer facing interactions such as audits, and customer complaint responses.
Successful candidates will have cGMP experience in pharmaceutical and/or medical device manufacturing environments, a data driven approach, and a willingness to work together as a team.
Essential Job Responsibilities:
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
Basic Qualifications:
Preferred Qualifications:
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to wet (non-weather); fumes or airborne particles; toxic or caustic chemicals. The employee is frequently exposed to work near moving mechanical, pneumatic, hydraulic, or pressurized parts. The noise level in the work environment is usually moderate.
Physical Demands: 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. The employee is regularly required to stand. The employee is frequently required to walk; use hands to finger, handle or feel and reach with hands and arms. The employee is regularly required to sit. The employee regularly lifts and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include Close vision, Color vision, Peripheral vision and Depth perception.
As an Equal Opportunity Employer, ILC Dover is committed to a diverse workforce. We offer competitive benefits including medical, dental, life insurance, 401(k), PTO, and more.
Background Check & Drug Screening Required
E-Verify Used
EOE/AA Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran
