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Sr Quality Systems Specialist(Remote)

Date: Sep 16, 2021

Location: JACKSON, MI, US

Company: Consumers Energy

Join the diverse and dynamic team that powers Michigan's largest energy provider and one of the nation's largest gas and electric combination utilities.  Consumers Energy services 6.7 million of Michigan's 10 million residents - caring for our friends and neighbors in all 68 Lower Peninsula counties.  We embrace a cleaner and leaner utility vision focused on eliminating energy waste and adding renewable energy from sources such as wind and solar.

At Consumers Energy, we offer more than just a place to work. We foster a culture that supports career development, growth, and stability, and we take pride in offering our co-workers excellent benefits and compensation packages. We are deliberately creating an inclusive culture that makes our diverse team of co-workers feel valued, supported, and empowered every day. We're a company made up of thousands of people, all with different stories to share and work to do, but we stand united in our company purpose: world class performance delivering hometown service.

 

DEPARTMENT SUMMARY

The Quality System and Compliance Team provides Quality System and Compliance support to the Energy Services Organization.  Typically, employees in this job family are required to possess or be willing to acquire specific certifications related to Quality System and/or Compliance.

 

JOB DESCRIPTION/RESPONSIBILITIES

The Sr. Quality System Analyst II develops, updates, and maintains the Quality Management System and Software.  Additionally the Sr. Quality System Analyst II has other responsibilities such as performing Regulatory Compliance Intake, Quality Management System coordination, leading audit teams and activities,  as well as leading and supporting, record retention, root cause analysis,  Corrective Action Preventive Action  (CAPA), complaints, risk management and control plan reviews. Additionally, the Sr.  Quality System Analyst II assists in developing/finalizing documentation for use in Quality Management System by ensuring proper formatting, identifying roles/responsibilities, helping close process gaps, and incorporating compliance requirements/controls.                

Essential duties and responsibilities include:

  • Quality Management System (QMS) Development/Maintenance Activities:   Develop, update, and maintain Quality Management System Initial Requirements/Software Configuration to include: Change Management, Document Control, and Training.
  • QMS Development/Maintenance Activities:   Develop, update, and maintain Quality Management System Core Requirements/Software Configuration to include:  Risk Management, Records, Process Controls/Plan, Corrective Action Preventive Action (CAPA), Audits, Complaints.
  • Regulatory Compliance Intake/Activities:  Develop, update and maintain Regulatory Compliance Processes and Requirements. Compliance Stakeholder.
  • Technical Writing:  Assist in developing/finalizing documentation for use in Quality Management System by ensuring proper formatting, identifying roles/responsibilities, helping close process gaps, and incorporating compliance requirements/controls.
  • QMS Improvement Activities:   Development, update, and maintain Quality Management System Additional Requirements/Software Configuration to enhance user experience, provide customized workflows and functionality. 
  • Quality System Coordinator:  Create and process Change Management and Document Control Items.  Create and Update Training Users and Requirements.  Create and process CAPAs.  Create and process Complaints.  Process Records.
  • Audits:  Perform Audits.  Lead Audit Teams and activities.
  • Risk Management/Controls:  Lead and support Risk Management and Control Plan reviews.
  • Data Analytics:  Develop and implement methods of monitoring, measuring, analyzing, and evaluating Quality and Compliance data.

 

This position will be located at the Innovation Center in Jackson or remote.

 

Required Qualifications:

  • Minimum 7 years of experience with Development of Quality Management System Elements, Regulatory Intake, Technical Writing, and Process Improvements.
  • Bachelor’s degree in Engineering, Technical discipline or equivalent experience

                               

Preferred Qualifications:

  • Quality or Compliance Certifications such as, but not limited to, Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) , Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Improvement Associate (CQIA), Certified Quality Process Analyst (CQPA), and/or Certified Compliance & Ethics Professional (CCEP)

 

ESSENTIAL KNOWLEDGE/SKILLS/ABILITIES

  • Experience developing Quality Management Systems and using Quality Management System Software.  Experience with EtQ Reliance is a plus.  
  • Experience with regulatory intake and with developing documentation to communicate regulatory requirements.  
  • Extensive experience using Technical Writing to document processes/requirements and with formatting documentation.
  • Experience with development and implementation of process improvements.    
  • Experience developing requirements for, as well as, leading Root Cause Analysis, CAPAs, and Complaint activities and defining record retention requirements.   
  • Experience developing requirements for, as well as, performing and leading internal audits and participating in external audits.
  • Experience leading the creation and update of Risk Registers and Control Plans. 
  • Experience developing and implementing methods of monitoring, measuring, analyzing, and evaluating Quality and Compliance data.    

Ability to work independently and to lead interdisciplinary teams.            
 
HOURS AND TRAVEL

This position requires the individual work a minimum of 40 hours per week (45-50 typical) in an office setting with potential for minimal travel.  Individuals need to be willing to work additional hours as necessary to meet deadlines.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to sit; stand; walk; and stoop, kneel, crouch, or crawl; use hands to finger, handle, or feel objects, tools, or controls; and reach with hands and arms. The employee frequently is required to talk or hear.   The employee must frequently lift and move up to ten pounds and occasionally lift and move up to fifty pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

 
All qualified applicants will not be discriminated against and will receive consideration for employment without regard to protected veteran status, disability, race, color, religion, sex, sexual orientation, gender identity or national origin.


Nearest Major Market: Jackson Michigan
Nearest Secondary Market: Ann Arbor

Job Segment: Engineer, Quality Manager, Law, CAPA, Quality, Engineering, Legal, Management