We are seeking a skilled and detail-oriented Quality Engineer to lead quality initiatives and ensure that manufacturing processes and products meet all regulatory, customer, and company standards. The ideal candidate will play a key role in driving continuous improvement, reducing waste, and ensuring product reliability and compliance.
- Develop, implement, and maintain quality standards and procedures to ensure product compliance with specifications and regulatory requirements.
- Analyze manufacturing processes for improvement opportunities and lead quality-related projects (e.g., FMEA, root cause analysis, corrective actions).
- Work closely with cross-functional teams (Engineering, Production, Supply Chain) to resolve quality issues and improve product performance.
- Conduct internal and external audits to ensure compliance with ISO 9001, or other applicable standards.
- Support new product introductions (NPI) by defining quality requirements and ensuring proper validation and qualification processes.
- Perform statistical analysis and use quality tools (e.g., SPC, Six Sigma, Minitab) to monitor and improve process capability and performance. Where Applicable
- Lead investigations into customer complaints and non-conformances; implement corrective and preventive actions (CAPA).
- Interface with suppliers on quality-related matters, including audits, inspections, and issue resolution.
- Create and maintain documentation such as control plans, inspection instructions, PFMEAs, and quality reports.
- Support the development and maintenance of Quality Management Systems (QMS).
- Bachelor’s degree in Engineering (Mechanical, Industrial, Manufacturing, or related field).
- 3+ years of experience in a quality engineering role within a manufacturing environment.- Knowledge of quality systems and standards (ISO 9001, AS9100, IATF 16949, FDA/GMP, etc.).
- Proficient in root cause analysis, statistical analysis, and quality tools (e.g., 8D, Fishbone, Pareto, 5 Whys).
- Experience with APQP, PPAP, FMEA, and control plans (especially in automotive or regulated industries).
- Strong analytical, problem-solving, and organizational skills.
- Proficient in Microsoft Office and quality software (e.g., Minitab, QMS platforms).
- Excellent communication and interpersonal skills.
- Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt certification.
- Experience in Lean Manufacturing and Continuous Improvement initiatives.
- Working knowledge of ERP systems (e.g., SAP, Oracle, or similar).
- Ability to spend time on the production floor.
- Occasionally lift up to [25/50] pounds.
- Work in a fast-paced, deadline-driven manufacturing environment.