Sr. Quality and Compliance Engineer
WinSystems is seeking a seasoned candidate for the position of Sr. Quality and Compliance Engineer at our corporate headquarters in Arlington, TX. WinSystems manufactures and distributes Engineered Embedded Solutions driving the innovative technology products of tomorrow with our industrial computers, I/O modules, power supplies, and custom designs.
This position reports to the Director of Technology and Engineering, and is the sole Quality and Compliance representative of the company. The primary responsibility of this position is to maintain the corporate Quality Management System (QMS) and Compliance policies and procedures; ensuring adherence to customer, industry, and regulatory requirements. The successful candidate will be a confident, influential Quality and Compliance advisor, with the proven ability to provide leadership, guidance, and support; and drive change for continuous improvement.
Key Performance Indicators:
• Advance the corporate QMS and Compliance systems, positively impacting company performance.
• Research, recommend, and drive implementation of Quality and Compliance systems, standards, software, policies and procedures, toward efficiency and best in class operations.
• Develop, implement, and drive consistent corporate Quality and Compliance policies and procedures.
• Develop and execute on long and short term corporate and job function goals and objectives.
• Lead, influence, and drive a corporate culture of Quality and Compliance efficiency and excellence.
• Excellent communication, collaboration, teamwork, and leadership skills
• Self-driven, disciplined, results-oriented, and an independent learner
• Strong analytical, technical, and detail orientation
• Excellent project management, organizational, and problem-solving skills
• Ability to influence management, peers, and other colleagues without direct reporting lines
Essential Job Functions:
• Develop and implement continuous improvements and efficiencies, in accordance with current ISO9001 standards; staying current to standards and industry best practices.
• Define, develop, and maintain regulatory Compliance guidelines and auditing procedures.
• Establish, implement, and monitor Quality control metrics for system effectiveness.
• Create and maintain QMS program documentation.
• Direct all internal and external Quality audits. Serve as Company Representative.
• Conduct, coordinate, or oversee QMS training classes, per program requirements.
• Resolve Quality issues via structured Quality methods, such as root cause analysis and corrective and preventive actions. Ensure potential or existing Quality or Compliance issues are addressed effectively and appropriately. Track and
measure effectiveness of corrective actions, and conduct/coordinate training as appropriate.
• Assist Operations management with manufacturing partner qualifications.
• Coordinate responses to regulatory authorities (e.g., the FDA); FDA Form 483 responses, FARs, etc.
• Ensure that controlled documentation is generated, revised, approved and maintained per corporate and regulatory agencies procedures.
• Interface with supplier and customer Quality representatives regarding Quality control, corrective actions, and Quality/Compliance information requests.
• Guide, instruct, and coach members of the leadership team on Quality and Compliance issues, trends and losses.
• Work with company Sales and Manufacturing personnel to ensure customer Quality and Compliance agreements are maintained/approved in accordance with established internal guidelines.
• Ensure that departmental performance meets the expectations of customers (internal and external) and supports the achievement of broader business goals
• The ideal candidate will possess 10+ years of direct work experience in a manufacturing environment, including QA experience in Printed Circuit Board Assembly (PCBA) and Box Build processes.
• Strong knowledge of PCBA regulatory Compliances; e.g. REACH, RoHS, CMRT, UL, FCC, cGMP, and CE.
• Strong knowledge of ISO standards, including QMS and IPC-A-610.
• BA/BS degree in a technical field or equivalent experience in Quality/reliability, and process engineering.
• Experience with appropriate Quality management tools and methodologies, for a manufacturing environment.
• Experience with establishing and measuring Quality metrics, such as Statistical Process Control (SPC), Process Capability (CP), Process Capability Index (CPK), Process Performance (PP), and Process Performance Index (PPK).
WinSystems offers a competitive compensation and benefits package including health, dental, and vision insurance; company paid life and disability insurance; 401(k); paid holidays and PTO. WinSystems is an Employee-Owned company and thereby offers qualified employees participation in the Employee Stock Ownership Plan (ESOP).