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Quality Assurance Engineer
2 months ago
Position Summary:
The Quality Engineer within the PharmBio division plays a crucial role in supporting pharmaceutical containment manufacturing operations on a daily basis. This role leverages expertise in ILC Dover's quality systems to ensure adherence to ILC Dover, ISO 9001, ISO 13485, and customer specifications. The engineer will actively seek out continuous improvement opportunities and engage in collaborative efforts to realize these enhancements. Additionally, the quality engineer may engage in customer interactions, including audits and responses to customer complaints.
Key Responsibilities:
- Develop and execute audits and control plans to guarantee that product quality objectives are achieved.
- Establish, define, implement, and monitor quality assurance key performance indicators and standards.
- Analyze non-conformances and customer complaints, lead root cause investigations, implement corrective measures, and track progress and improvements.
- Promote continuous enhancement of quality standards, requirements, and best practices.
- Create and manage quality systems documentation, including quality manuals, procedures, and work instructions.
- Design sampling procedures and develop forms and instructions for documenting, assessing, and reporting quality and reliability data.
- Utilize statistical process control (SPC) techniques to analyze data for evaluating current processes and changes.
- Prepare and present technical and program information to team members and management.
- Supervise technical and administrative personnel involved in quality activities.
- Maintain up-to-date knowledge of government and industry quality regulations and standards, including ISO 9001 and ISO 13485.
Qualifications:
- Bachelor's degree in Engineering or a related technical field.
- At least 3 years of relevant experience.
- Proficient in CAPA, root cause analysis, and 8D methodologies.
- Six Sigma Green Belt or Black Belt certification.
- Strong analytical and problem-solving abilities.
- Excellent written and verbal communication skills.
- Detail-oriented with strong organizational skills.
- Proficient in word processing, statistical analysis software (SPC), graphics software, order processing software, and database management.
- Skilled in Microsoft Office Suite.
- Experienced with precision measurement tools, calibration, and testing equipment.
Preferred Qualifications:
- Experience in the Pharmaceutical/Medical Device Industry, particularly in Quality Control or Engineering roles.
- Familiarity with clean room and aseptic manufacturing environments.
- ISO 13485 Internal Auditor certification.
Work Environment: The characteristics of the work environment described here are typical of those encountered while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Employees may occasionally be exposed to wet conditions, fumes, or airborne particles, as well as toxic or caustic chemicals. Frequent exposure to moving mechanical, pneumatic, hydraulic, or pressurized components is expected. The noise level in the work environment is generally moderate.
Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Employees are regularly required to stand, walk, use hands for handling or feeling, and reach with hands and arms. Employees must be able to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required include close vision, color vision, peripheral vision, and depth perception.
Background checks and drug screenings are required.
E-Verify is utilized.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
