Quality Assurance Engineer
2 weeks ago
Position Summary:
The Quality Assurance Engineer plays a crucial role in assisting the Quality Management team with the execution of comprehensive operational procedures and processes that underpin the overall Quality Assurance strategy. This position is pivotal in fostering quality enhancements across the production floor and within collaborative team environments, actively engaging as a member of cross-functional teams focused on achieving specific objectives.
The Quality Assurance Engineer will systematically analyze and deliver defect data from diverse sources to prioritize critical issues for resolution, aiming for zero defects. This role involves spearheading root cause analysis and problem-solving initiatives within the team, utilizing approved problem-solving methodologies. Additionally, the engineer will develop criteria for defect detection that teams can monitor during the assembly process, ensuring that all manufactured products adhere to customer specifications while maintaining the highest quality standards and fulfilling the company's performance goals.
Key Responsibilities:
- Support and uphold the ABEC Quality program.
- Ensure adherence to ABEC Standard Operating Procedures (SOPs).
- Maintain and promote ABEC quality practices and guidelines.
- Engage in internal and vendor audits as required.
- Participate in Factory Acceptance Testing (FAT) and Installation Qualification/Operational Qualification (IQ/OQ) activities as assigned.
- Coordinate assigned Corrective and Preventive Action (CAPA) initiatives, including root cause analysis and both short- and long-term corrective actions.
- Facilitate assigned Continuous Improvement (CI) projects.
- Review, approve, and manage Engineering Change/Release Notices (ECNs).
- Complete Document Control and Change Management tasks as directed.
- Maintain documentation within ABEC archives.
- Support new product development initiatives as directed.
- Execute additional tasks as assigned, including those related to Quality, Projects, and Product Development.
- Adhere to all safety regulations and policies.
- Travel as necessary.
- Actively identify and promote Continuous Improvement (CI) opportunities.
Qualifications:
- Bachelor's Degree in Chemical, Mechanical, or Electrical Engineering is preferred.
- 3-5 years of relevant experience in a quality-related field.
- Familiarity with cGMP, ISO 9000, Six Sigma, and Certified Quality Engineer (CQE) standards.
- Strong interpersonal and problem-solving abilities.
- Excellent written and verbal communication skills.
- Detail-oriented with strong prioritization skills.
- Adept at multitasking.
- Proficient in Microsoft Office Suite, particularly Outlook, Word, and Excel.
- Experience with Continuous Improvement (CI) methodologies is advantageous.
- Prior experience with Lean/Six Sigma principles is a plus.
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