Quality engineer

ACS Solutions has an immediate need for an Sr. Quality engineer with experience in the medical device Industry. This is a Full-time opportunity and is located in Corona, CA . Our client is a leading Chemicals company.Please review the job description below:

• Develops, writes, and assists with the implementation of effective quality assurance controls
• Writes validation and verification plans and protocols; assists with IQ/OQ/PQ activities, including finalizing reports.
• Coordinates the identification, assignment, monitoring, and completion of process and/or product improvement projects.
• Partners with the operations and engineering functions to coordinate pilot production of new products.
• Coordinates the reporting, analysis, and resolution of material nonconformance occurrences.
• Applies statistical and quality tools to analyze data and perform thorough Root Cause Analysis (e.g., Fishbone Diagram, 6M, 5Whys), execute CAPA processes and improve process capabilities (e.g.,5S, Lean, 6 Sigma, DOE, SPC).
• Conducts risk analysis; creates or revises control plans for new and existing products.
• Completes projects in a manner consistent with corporate objectives.
• Provides support in the rapid resolution of product complaints and/or safety issues.
• Provides quality assurance appraisal of suppliers.
• Conducts quality process and product audits and develop responsive corrective action plans.
• Applies technical writing skills to document current practices to meet quality requirements necessary for QMS.
• Supports completion of customer requests (e.g., supplier surveys, EU MDR compliance declarations, etc.).
• Provides specific support for operational quality management system programs.
• Performs other duties as assigned.

• Bachelor’s Degree in an engineering or technical discipline
• At least 2 years’ experience in medical device industry.
• Understanding of ISO 13485, FDA 21CFR Part 820, cGMP and working knowledge of regulations (e.g., EUMDR, REACH, RoHS, etc.)
• Solid understanding of the fundamentals of statistics. Familiarity with SPC.
• Experience and familiarity with tools of root cause analysis and defect analysis, including Failure Mode and Effect Analysis (FMEA).
• Experience developing and implementing process controls, corrective and preventive action, and product quality improvement.
• Experience with DOE.
• Experience with verification and validation activities. Ability to conduct process analysis, and capability assessments. Able to develop and establish Control Plans, FMEAs, PPAPs.
• Familiarity with test methods validations or measurement systems analysis, test and inspection equipment, and valid acceptance sampling plans.
• Experience with quality management systems.
• Excellent written and verbal communication skills. Ability to lead and influence others to drive change.
• Excellent project management skills.
• Experience with Lean or Six Sigma manufacturing principles.
• CQE Certification a plus.

• Analysts international Corporation (Staff Augmentation Services)
• The Ascent Services Group Inc. (Life Sciences Talent Solutions)
• HireGenics, (Payrolling, IC Compliance, & MSP Services)
• DATA Inc. (Information Technology- staffing)

• 6th largest IT staffing firm in the US. (Staffing Industry Analysts (SIA) 2019)
• Largest Minority IT Staffing Firm in the US. (SIA 2019)

• ClearlyRated® 2020 Best of Staffing award winner for providing remarkable service quality to our clients. This is our ninth consecutive win.

• Microsoft Gold Partner: Application Development, Cloud Platform, Data Analytics, Data Center, DevOps, Data Platform
• AWS Managed Services Partner
• Google Cloud Partner
• ISO 27001:2013 Certified for Data Security
• ISTQB Gold Partner
• ISMS (ISO 27001:2017)
• SOC2 Type II Compliant