Global Quality Manager
Life Sciences
Michigan
We are seeking talented individuals to join our growing team!
CONVERGIX Automation Solutions leverages the strengths, experience, and capabilities of our existing businesses, along with new talent, to transform and grow into the ultimate automation solutions trusted partner, capable of solving any industrial automation challenge.
Convergix Automation Solutions is looking for a Global Quality Manager to join our growing team in order help us grow into the ultimate solutions trusted partner in the industrial automation space. Reporting to the VP Continuous Improvement and PMO, the successful candidate will be responsible for planning, developing and formalizing the organization's Global Quality Management System within our Global Business Units. You will be instrumental in leading the effort to obtain ISO9001 registration for three North American facilities and combining them with our UK facilities who are already registered, working cross-functionally with teams to improve quality strategies and processes, ensuring compliance with customer and regulatory requirements. Additionally, you will coach and train employees on quality-related topics, manage non-conformance resolutions, and report on the performance of the QMS to top management.
What would a typical day be like?
* Develop a comprehensive plan to obtain ISO9001 registration for all CGX entities that are not already registered.
* Formalize the organization's Quality Management System (QMS) and ensure it conforms to customer, internal, ISO 9001, and regulatory/legal requirements.
* Lead, organize and perform internal ISO audits.
* Oversee the restructuring and maintenance of CGX documentation control library.
* Participate with our supply chain management department in the evaluation of, and reporting on, Supplier quality systems.
* Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization's products.
* Work with CI Specialists to constantly monitor, coach and improve GEMBA board content
* Work with customers, employees, contractors, and outsourcing firms to align internal and external project requirements related to quality such as IQ/OQ/PQ and 21 CFR Part 11 of the Code of Federal Regulations
* Coach and consult with functional managers to ensure CGX's interests are protected while meeting customer expectations.
* Deliver training to CGX employees on topics such as Overall Equipment Effectiveness, Measurement System Analysis, Gauge R&R and Statistical Process Control.
* Report to top management on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement.
* Conduct periodic management review meetings required to meet our QMS commitments.
* Responsible for accuracy and timely inspection/calibration of monitoring and measuring devices.
* Keep up on standards, regulations/laws, issues, and news with respect to product (service) quality.
* Lead the Quality function including Supplier Quality, In-Process Quality, Product Testing, Final Inspection, and Customer Service.
* Ensure that quality strategies and processes are in place to meet business objectives and operational needs in terms of cost, quality, and delivery targets.
* Provide department leadership supporting strategic initiatives.
* Ensure customer quality issues and non-conformances are resolved in a timely manner by confirming root cause and corrective actions utilizing DMAIC and by partnering with functional managers such as Build, Manufacturing, Mechanical and Controls Engineering, Controls Techs and Procurement.
* Identify and pro-actively lead continuous improvement actions to prevent non-conformances working closely with internal and external stakeholders.
* Ensure strong communication with other functions in the organization, facilitate exchange of information in order to implement change and improvements regarding quality.
* Establish Quality Performance data and Key Performance Indicators, report on Quality activities on a regular basis to the Management team.
What qualifies you for this opportunity?
* Bachelor's degree in engineering discipline and 5+ years related Quality Managerial experience; or 8-10 years related managerial experience and/or training.
* ASQ certified MQ/OE or SSBB or MBB or QE or QA or RE or SQP.
* Experience in the Life Science or Medical Device Industries
* Proven work experience with a variety of concepts, practices, and procedures used to create and maintain a Quality Management Systems.
* Experience conducting ISO audits internally or externally.
* Demonstrated technical competency in Continuous Process Improvement and Lean Six Sigma methodologies.
* Experience with statistical analysis software is desired. Minitab preferred.
* Experience with Non-Conformance Reporting software.
* Experience with Verification and Validation Engineering is highly desirable
* Knowledge and understanding of electronic and mechanical systems as well as knowledge of testing processes, methodologies, and failure analysis.
* Advanced technical writing skills and the creation of standard operating procedures
* Ability to travel internationally
Physical Demands:
* While performing the duties of this position, the employee is regularly required to stand, walk, sit, use hands to feel objects, reach with hands and arms, stoop, kneel, talk and hear.
* Specific vision abilities required for the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
* Occasionally lifts or moves up to 25 pounds
What does CONVERGIX Offer You?
Here at CONVERGIX, we offer a very generous compensation and benefits package including:
* Comprehensive benefits and 401K/RRSP packages (including health, dental, vision coverage and more!)
* Clear paths for career advancement and opportunities for professional development
* Hands on experience with the latest automation technologies and tools
* The chance to be part of a globally recognized workplace that consistently develops cutting-edge solutions that set industry standards
* A diverse and inclusive atmosphere that provides support for employees from all walks of life
ABOUT CONVERGIX AUTOMATION SOLUTIONS
Convergix Automation Solutions designs, engineers and integrates hardware and software to automate its customers' operations. Convergix specializes in creative, custom solutions and serves customers in a broad range of industries. With over 900 employees and 19 locations worldwide, Convergix is a leading global diversified automation provider. Our vision is to become the ultimate trusted partner, capable of solving any industrial automation challenge with our passionate people, world-renowned processes and diverse experience.
Learn more about us: https://convergixautomation.com/
What does CONVERGIX value?
Our values are our foundational concepts on which we build CONVERGIX; we adhere to these no matter what mountain we climb.
* Integrity - Respect, Transparency, Commitment
* Excellence - Continuous Improvement, Innovation, Collaboration, Communication
* Passion - Momentum, Sense of Urgency, Growth, Success, Velocity
We thank all candidates for their interest, however only those considered for an interview will be contacted.
CONVERGIX Automation Solutions has an accommodation program in place that provides reasonable accommodations for employees with disabilities. If you require a specific accommodation because of a disability or a medical need, please contact Human Resources.