Quality Solutions Engineer
hace 1 mes
Your journey to building a better world starts here
WHO WE ARE
We help create products that build a better world across a variety of industries:
- Healthcare and Life Sciences- Aerospace and Defense- Industrial
Some examples of products include:
- Ultrasound units- Robotic surgical devices- Molecular diagnostics instruments-
- Electric-assist Bicycles
WHY WE LOVE IT
At Plexus, we’re at our best when opportunities are met with passion, open communication and teamwork. Our engineers work alongside a global team of experts who engage in projects that span a variety of industries - helping our customers in creating the products that build a better world.
At Plexus, you will find:
- A workplace centered on collaboration and integrity- Supportive leadership teams that value work life balance through a flexible work environment- An inclusive environment which values diverse backgrounds, experiences and expertise- Flexible career paths across a variety of disciplines- Innovative design solutions and state-of-the-art technology that improves lives
HOW YOU WILL DO IT
Purpose Statement: Provide support and leadership in order to effectively design, develop, monitor, maintain, and continuously improve the quality management system in alignment with Plexus strategies and values to ensure services are capable of meeting business needs.
Key Job Accountabilities:
- Audit Support - Conduct/Support internal audits and host/support external audits and regulatory inspections.- Process Deployment and Continuous Improvement - Lead and drive innovative QMS improvements to ensure global process deployment and effective implementation. Leads the overall assigned quality system elements, ensuring global process deployment, oversight and usage while driving innovation and continual improvement of the systems and related tools.- Process Documentation and Training - Development, management, oversight, and globalization of Quality System documentation and training materials.- QMS Monitoring - Lead development, deployment and oversight of metrics for the (QMS) at the site, regional, and global level to ensure appropriate monitoring of the health and compliance of the processes.- QMS Process Compliance and Support - Lead elements of the Quality Management System (QMS), including: develop strategies, plan, implement, manage change and associate risk to ensure compliance with governing QMS requirements. Provide technical guidance and direction to regional and site management teams and leaders.
Additional Accountabilities:
- Provide guidance and support to applicable site and corporate functions as it relates but is not limited to: training content design and development, CAPA resolution, management review, metrics, quality documentation development, product data management and auditing.- Collaboration with Compliance, Supplier Quality, Human Resources, Operations and other applicable functions on QMS process and system strategies and best practices.- Lead regional and site quality system functional Subject Matter Expert knowledge, skill and process development, which includes identifying, defining and implementing improvements and best practices.- Technical site support and training as required for specific projects, needs, or issues.- Contribute to QMS planning and forecasting of expenses.-
- Assist management in compiling and organizing performance data and metrics for management reviews and reports.- Occasional travel may be required to meet the needs of the business (estimated 10-30%).- Additional duties as assigned.
Education/Experience Qualifications:
- A minimum of a Bachelor's degree of Science in Engineering or Technology is required; industry recognized certification (i.e. ASQ) is preferred.- Six (6) years of related experience is required; Eight (8) years of related experience is preferred.
An equivalent combination of education and experience sufficient to successfully perform the key job accountabilities may be considered.
Other Qualifications:
- Advanced working knowledge of quality systems and tools- Advanced working knowledge of design or manufacturing process standards- Advanced problem solving skills- Advanced and demonstrated Lean and Six Sigma skills- Advanced presentation skills- Advanced data analysis skills- Self-management capabilities- Advanced cross-functional team building skills across multiple sites/regions- Demonstrated ability to quantify and assess benefits/risks of process improvements- Mastery in multiple key Quality System processes- Job specific professional certification is preferred- Advanced knowledge of ISO9001 and other applicable industry standards- Advanced and demonstrated lead auditor skills- Strong and demonstrated risk management skills- Advanced computer skills and the ability to learn additional software packages- Advanced knowledge of database management- Advanced and demonstrated ‘systems thinking’ skills- Demonstrated ability to lead and multi-task in a dynamic and glob
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