Quality Assurance Engineer II
1 week ago
Job Overview: As a Quality Assurance Engineer, you will play a pivotal role in developing, modifying, and maintaining quality assessment systems and protocols for transforming raw materials into high-quality finished products. Your collaboration with engineering and manufacturing teams will be essential to uphold quality benchmarks.
Key Responsibilities:
- Lead and engage in project teams to effectively implement enhancement initiatives or improvements in manufacturing processes.
- Support manufacturing activities, including validation projects and equipment assessments, ensuring compliance with relevant regulations.
- Participate in ongoing improvement and Performance Excellence initiatives, including leading, coaching, and facilitating project teams.
- Provide technical support and direction to team members in enhancing Quality Systems.
- Utilize quality engineering practices to assist project teams and manufacturing operations, employing tools such as Six Sigma, FMEA, and Control Plans.
- Oversee the execution of validation protocols as needed.
- Develop and update Quality Plans, including inspection processes, and train affected personnel.
- Conduct technical reviews and analyze data for equipment and process performance accuracy.
- Draft Technical Reports and Protocols, and review and revise Standard Operating Procedures (SOPs).
- Interact regularly with colleagues, supervisors, and cross-functional teams.
- Manage the change management program to ensure thorough technical reviews and risk assessments.
- Oversee Corrective and Preventive Actions (CAPAs) to ensure effective resolutions.
- Engage in Material Review Board (MRB) activities, ensuring thorough root cause analysis and appropriate corrective measures.
- Analyze Quality System metrics and recommend corrective actions as necessary.
Performance Metrics:
- Quality
- Culture
- Cost
- Customer Satisfaction (Product Quality)
- Continuous Improvement
Competencies:
- People Skills: Quick learner, approachable, active listener, interpersonal savvy, patient, and perseverant.
- Business Acumen: Action-oriented and customer-focused.
- Leadership Qualities: Clear communication of team goals, expertise in project execution, and commitment to continuous improvement.
Qualifications:
Required:
- Bachelor's degree in microbiology, chemistry, biology, engineering, or related fields with 4-7 years of relevant experience.
- Ability to balance team and individual responsibilities.
- Proficient in basic mathematical concepts applicable to practical situations.
- Basic knowledge of Microsoft Word and Excel.
- Detail-oriented with strong technical writing skills.
- Able to work independently and collaboratively.
Desired:
- Advanced degree in a relevant field.
- Familiarity with regulatory standards such as cGMP, ISO 9001, and ISO 13485.
- Certification as a Quality Engineer by ASQ.
- Proven track record of delivering results.
- Experience with Six Sigma and Lean methodologies.
- Proficiency in statistical software such as Minitab and project management tools.
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