Compliance Project Engineer

Project Engineer Position - Monrovia, CA

Monday through Friday - 7 am to 4 pm

Position Summary:

Under the general supervision of the Director of Compliance, the Compliance/Project Engineer will support all audit programs, including but not limited to; internal audits, customer audits, and supplier audits. Will lead and be the point of contact for all audit programs from start to finish. Audit activities to include but not limited to pre-audit planning and audit program drafting; identification and assessment of risks; reviewing for compliance with policies, procedures, and regulatory requirements; pulling and analyzing reports from external portals; offsite assessments of customer and/or supplier facilities; drafting initial findings and audit reports; and providing sound recommendations for improvements or corrective action. In addition, Compliance/Project Engineer will work in partnership with other departments within the Company.

Essential Functions:

• Provide technical support on the development, implementation, maintenance, and improvement of the companies AS9100, ISO9001, ISO13485 & ISO27001 BMS including related processes and their interactions.

• Ensure compliance with national and international standards and legislation.

• Communicate with internal and external interested parties on matters relating to the BMS.

• Help monitor all operations that affect the implementation and execution of BMS.

• Complete desk audits and self-surveys.

• Help other departments analyze compiled data from tests and inspection reports to identify problems. Review results with upper management, advise and make recommendations accordingly.

• Promote companywide continuous improvement efforts.

• Write policies and procedures.

• Participant with different departments to plan, formulate comprehensive procedures and other areas such as Risk Management review.

• At times may be required to participate in the Roncelli training program as a trainer to other staff members.

• If needed participate in management meetings and provide insight into the overall strategic plan.

• Work with the Director of Compliance to set and review the budget for the Compliance department and analytically review activities and cost that pertain to the compliance operations to determine the progress of the business towards stated goals and objectives. Ensure costs are kept within the established budget and that sound accounting practices (budget and financial controls) are in place and being implemented at all levels within compliance operation.

• Lead Lean Six Sigma Projects, Kaizen events and 6’s implementation.

• Assist company safety program, in coordination with Human Resources.

• Assist on FOD Prevention program in coordination with Department Managers.

• Business Continuity and Recovery Plan Maintenance, in coordination with Leadership Team. Compliance/Project Engineer

• Oversee the process related to capturing data associated with product deviations, product NonConformances (NC) Corrective/ Preventive Actions (CPA), complaints, scrap, and rework. Analyze the data for quality improvement, create a report for upper management and advise according.

• Lead annual Internal Audits and Management reviews.

• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality reliability data.

• Establishes programs to evaluate precision and accuracy of production equipment and testing, measurement, analytical equipment, and facilities.

• Monitor Key Performance Indicators [KPI] throughout the company, gathering relevant data and producing statistical reports.

• Support monthly KPI Review with management team and process owners. Advise on improvement plan.

• Bring staff together from different departments to plan, formulate comprehensive quality procedures and other areas such as Risk management review.

• Perform lean and process improvement projects in a team environment.

• Ensure that proper management tools are in place to develop and control all aspects of operations including cost containment programs, scrap reduction, equipment utilization, plant layout, total quality, coordination with other functions, and human resource utilization.

• Analytically review activities, cost, operations and forecast data to determine the progress of the business towards stated goals and objectives.

• Work with Materials Manager to evaluate supplier quality data to identify process improvement opportunities within the supply chain. Collect and maintain supplier performance metrics.

• At times, may have to be available for Roncelli Malaysia time zone meetings.

• Perform other tasks and/or projects as assigned. •

Skills, Knowledge, and Experience:

• Minimum of 5+ years in related field.

• Bachelor’s Degree in engineering or related field preferred.

• Experience with AS9100, ISO9001, ISO13485 & ISO27001 standards and internal audit procedures required.

• Thorough knowledge and understanding of the Inspection/Quality process.

• Proficient in quality tools such as 5Why’s, 8D, SPC, PFMEA, PPAP, Pareto chart, etc.

• Strong problem-solving skills with ability to teach basic problem-solving techniques.

• Strong data analysis and reporting skills.

• Proficient in MS Office (e.g., Word, Outlook, Excel) and Internet.

• The ability to use JobBoss, DocuWare, UniPoint, Outlook is a plus.

• Excellent written and verbal communication skills.

• Ability to adapt quickly to changing priorities and respond to unforeseen requests.

• Ability to interface with all levels of employees and management.

• Blackbelt or Greenbelt certification would be a plus.

• Proficient in Unipoint and/or Minitab software preferred.