IMI Precision Engineering Quality & Compliance Engineer in Concord, California
Develop, implement, and administer quality assurance procedures, plans and control systems. Serve as a resource for compliance, industry standards and to improve product/process quality and reliability. Lead teams that address quality issues using risk analysis and root cause analysis tools. Support new product development efforts. Provide quality and compliance leadership and training to employees throughout the organization. May fulfill the position of Acro’s ISO Quality Representative.Champion the company-wide continuous improvement (Lean-Kaizen) programs. Maintain a safe and productive work environment that is consistent with the company culture.
• Dependent upon experience, the position may be classified as Hourly vs. Exempt.
• Basic knowledge of commonly-used concepts, practices and procedures involved with quality engineering and regulatory compliance.
• Rely on instruction, guidelines, and leverages the experience of others to accomplish tasks.
• Exercise limited independent judgment and work on an assignment basis.
• Advancing knowledge of concepts, practices and procedures involved with quality engineering and regulatory compliance.
• May rely on experience and some independent judgment to accomplish tasks, while being willing to take instruction from others.
• May mentor others on the quality team and train on quality, compliance and industry standards.
• May lead MRB, CCB, and SMC projects/tasks on an assigned basis.
Education and Experience:
• Bachelor’s degree in mechanical engineering, quality or related technical discipline
• Ref. above Job Levels for experience requirements
• Demonstrated experience in applying quality standards (i.e., ISO 9001) and process improvements (i.e., Lean).
• Practical experience with quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, Design of Experiments (DOE), Gauge Repeatability & Reproducibility (R&R), trend analysis, etc.)
• Experience with Corrective and Preventive Action (CAPA) and failure investigation tools and techniques.
• Ability to identify problems and use solid judgment in selecting analysis methods and techniques for obtaining options and/or solutions.
• Excellent verbal, listening, application and written communication skills, including the ability to train and educate others.
• Ability to be flexible in a dynamic work environment with shifting priorities.
• Proven tact and good judgment in critical situations. Possess skills to negotiate and reconcile differences.
• High level computer literacy skills and aptitude. Create written documents, utilize excel for analytics, communicate via email, and perform other tasks utilizing Microsoft office based programs. Ability to learn Enterprise specific computer programs, including ERP systems, Salesforce (CRM), Quality Management and analytical software.
• Valid California driver’s license. Maintain a driving record that meets the guidelines established by Enterprise’s insurance carrier. Position requires driving to suppliers and customers.
• Must be able speak, read, write, and understand the primary language used in the workplace: English.
• ISO 13485, Medical device manufacturing experience
• ASQ Certification (e.g., Certified Quality Engineer (CQE)) (Applies to Senior Engineer, Acro to provide training opportunities)
• Regulatory compliance and industry standard’s experience
• Certified ISO Lead Auditor (Acro will train)
• Certified Lean Six Sigma Black Belt (Applies to Senior Engineer, Acro to provide training opportunity)
• CMM programming skills (Acro will train)
Job ID 2019-31837
# of Openings 1
Platform IMI Precision Engineering