Logo
Innovize

Senior Quality Engineer

Innovize, St Paul

Save Job

Job Description
Title: Senior Quality Engineer, Production Focused Team
Reports to: Sr. Manager, QE
Summary: The Production Focused Team (PFT) Senior Quality Engineer (QE) will drive a Culture of Quality and Continuous Improvement within the company by promoting adherence to the Quality System requirements across all departments. This role is responsible for ensuring customer, company, and regulatory requirements are met or exceeded while simultaneously meeting company cost and productivity goals by supporting the continuous improvement and re-qualification of manufacturing and inspection processes.
The incumbent for this role is also responsible for applying risk-based established industry standard scientific and engineering problem-solving methods to identify, document, communicate, prioritize, and resolve quality issues (e.g. nonconformances, material review board, customer complaints, and corrective actions).
The PFT Senior QE is responsible for maintenance and update of process risk assessments, quality plans and control plans. Quality Engineer also provides cross-functional quality technical support to the owners of key support functions including but not limited to, supplier management, change management, environmental control, equipment/tooling control including calibration and preventive maintenance.
The PFT Senior QE is a key resource for the use of statistical techniques and validation activities (e.g. statistical process control, risk-based sampling, Gage R&R, Test Method Validation (TMV), DOE, process characterization, validation, and capability studies). Quality Engineer may occasionally provide support to the Quality System Compliance function by providing subject matter expertise during internal, supplier and external audits.
The role reports to the Sr. Manager, Quality Engineering.
Duties/Responsibilities include but are not limited to:
  • Follows all Quality Management System requirements and company procedures ensuring regulatory requirements are met, encourages all associates to do the same
  • Meets commitments on time with accuracy and attention to detail
  • Maintains current knowledge of applicable medical device regulations (FDA QSR, ISO 13485, ISO14971) and related standards or guidance documents.
    • Production-Production Focused Team:
Assures the Production Focused Team (PFT) meets or exceeds customer, company, and regulatory requirements by working as the PFT quality representative in support of manufacturing and process improvement. Provides on-the-floor quality support, as needed, to resolve production issues and to ensure proper implementation and use of process controls. Investigates and supports resolution of customer complaints, process or product nonconformities, and supplier quality issues. Identifies and implements opportunities for process improvement, new or revised process controls, improvements in productivity and costs. Maintains standard work for existing product processes. Supports customer or company-initiated changes to equipment, manufacturing location, processes, materials or product specifications.
  • As required, works with Development, Production, Quality, Sales, and Customers to create, document and execute/implement:
    • Risk assessments (PFMEAs)
    • Quality Plans and Control Plans
    • Production and inspection procedures including identifying and establishing incoming inspection requirements
    • Test method development and validation, gage R&R
    • Equipment installation qualification (equipment IQ/OQ) protocols and reports
    • Process characterization, risk-based process operational and performance qualification (OQ/PQ) protocols and reports
    • Establishing statistical process controls
  • Communicates with customers and within the organization to ensure potential nonconformances and potential product issues are identified and documented according to company procedures (i.e. nonconforming material, material review board, customer complaints, corrective actions, CAPA processes, customer notice of change, and supplier notice of change)
  • Provides technical expertise and uses industry standard Root Cause Analysis methods for product and process issues to ensure identification of assignable and root causes, identification and implementation of required containment and immediate corrections and long-term corrective actions
  • Provides expertise in risk-based sample size determination, and statistical analysis of data. Presents data and data analyses accurately and audience appropriate in presentations and/or reports
  • Supports continuous improvement (CI) and Lean initiatives, may lead or sponsor CI and Lean initiatives
  • Leads risk assessment activities for modified process improvement projects and equipment changes. Reviews and updates risk assessment documentation for new or revised risks based on nonconformities, customer complaints, change requests, and other Quality System inputs
  • Supports and provides technical expertise to many Quality processes including supplier management, Material Review Board, Change Control, Calibration, Preventive Maintenance, Equipment controls, Environmental controls, and other processes where out of specification, unexpected excursions or corrections are encountered
  • Acts as a subject matter expert for external audits as needed, may participate as part of the internal or supplier auditing team
  • Performs other related duties or related special projects as assigned by management
Training/Education/Experience:
  • Bachelor's degree in science, engineering or technical field
  • 5+ years in medical device or related fields, with direct experience related to job responsibilities
  • Understanding of statistical techniques, data management, investigation techniques, and technical writing
  • Excellent verbal and written communication skills, both internally and with customers in a professional manner
  • Critical thinking skills with desire to continue learning
  • Six-Sigma Green Belt (or higher) highly desirable
  • Well-developed written and verbal communication skills. Ability to present information to all levels within the organization, regulators, and customers
  • Results oriented, self-starter, who can work independently
  • Strong attention to detail
  • Organized and able to maintain organized records
  • Able to accommodate, track and deliver on multiple projects simultaneously
Competencies/Talents/Personal Attributes:
  • Proficient with Microsoft Office software, and familiar with ERP and statistical software (EPICOR, MiniTab or similar)
  • Able to create graphs and tabulate data using the appropriate software for the presentation of data
  • Ability to work in office setting.

Notes: This Job Description is intended to be an accurate reflection of the current job as of the document effective date. This job description is not intended to be an exhaustive list of all required skills, duties, responsibilities, or qualifications associated with the positions described herein. The company reserves the right to revise or amend the qualifications, functions and duties of the jobs or to require that additional or different tasks be performed if business circumstances change. Employees are held accountable for performing the duties of their position, as evaluated by documented scorecards and performance management reviews based upon company specified metrics and goals documented in the scorecard for which the employee is made aware and maintains.