Pivotal Solutions ยท 1 day ago
Quality Engineer (Medical Device Manufacturing exp needed) - Germantown, WI
Germantown, WI
Full-time
Onsite
Mid LevelPivotal Solutions is a company focused on medical device manufacturing, and they are seeking a Quality Engineer to develop quality systems and ensure that products meet performance and quality specifications. The role involves resolving quality issues, maintaining the Quality Management System, and supporting compliance with regulatory requirements.
ComputerManagement ConsultingSoftware
Hiring Manager
Christopher Correale
Responsibilities
Generates, communicates, and implements ideas and solutions
Demonstrates accuracy and thoroughness in completing tasks timely
Looks for ways to improve and promote quality
Monitor Corrective Action System (i.e. Customer Complaints, Supplier, Internal)
Initiate and investigate Customer Complaints according to our internal procedure and standards
Record essential information on internal and/or customer-specific documentation, including updating customer portals
Perform investigations using Lean, Six Sigma, and statistical methods to support root cause analysis and corrective actions
Identify gaps and/or trends in systems or processes
Initiate and facilitate the Corrective/Preventative Action process using the appropriate quality tools and input from subject matter experts (SME) to implement sustainable solutions
Update Quality documents according to our Change Control procedures, as required
Verify corrective action effectiveness
Drive Non-Conformance Process
Evaluate and investigate suspect non-conforming product identified by manufacturing and/or the Quality Lab
Initiate containment activities, as necessary, with Customer Service and Shipping Department
Recommend disposition of product based on thorough investigation and data-driven feedback
Initiate and assist Customer Service with Return Material Authorization (RMA) process
Develop re-inspection, sort, and/or rework instructions for Manufacturing Operators, as required
Collaborate with customer on issuing waiver or deviation documentation and obtain customer approval, as required
Maintain the Quality Management System (QMS)
Understand ISO 13485 Quality management systems requirements
Ensure continuing compliance to both internal processes as well as requirements imposed by certification bodies, regulatory agencies, and specific customer requirements
Assist in internal, 2nd party, and 3rd party audits
Assist with responses and corrective actions for audit findings
Support Product Realization process
Participate in design review, process planning, and failure mode analysis
Provide input on evaluation of Key Product Characteristics
Provide input on gaging methods and equipment
Interpret customer requirements including complex blueprints and GD&T call-outs
Review and approve Engineering Change Notifications and Verifications
Evaluate for feasibility and implement updates to customer requirements into associated product control plans, pFMEA, Inspection documentation and other related documents
Incorporate industry standard best practices
Incorporate lessons learned
Evaluate, submit and track Supplier Change Notices to customers and/or suppliers
Any other duties as assigned
Manufacturing point of contact for the review and disposition of product quality related questions
Approve Medical Device release for shipment, as required
Perform batch record reviews for medical device prior to release for shipment
Generate Certificate of Analysis, as required
Release product in ERP system based on customer and process requirements
Support Manufacturing process
Train Manufacturing and Quality Control personnel on customer requirements, inspection techniques, lessons learned, and rework instructions
Manage product inspection and testing activities
Obtain customer approvals for all required changes based on Quality Agreements
Compile supporting measurement and process performance data, as necessary
Assemble supporting documentation package and review for completeness and accuracy
Review and approve production documentation updates according to our Engineering Change Order process
Qualification
Required
Experience in medical device manufacturing
Strong technical resource with the ability to resolve quality problems
Ability to generate, communicate, and implement ideas and solutions
Demonstrates accuracy and thoroughness in completing tasks timely
Ability to look for ways to improve and promote quality
Experience monitoring Corrective Action Systems (Customer Complaints, Supplier, Internal)
Ability to initiate and investigate Customer Complaints according to internal procedures and standards
Experience recording essential information on internal and/or customer-specific documentation
Ability to perform investigations using Lean, Six Sigma, and statistical methods
Ability to identify gaps and/or trends in systems or processes
Experience initiating and facilitating the Corrective/Preventative Action process
Ability to update Quality documents according to Change Control procedures
Experience verifying corrective action effectiveness
Ability to drive Non-Conformance Process
Experience evaluating and investigating suspect non-conforming products
Ability to initiate containment activities with Customer Service and Shipping Department
Experience recommending disposition of product based on investigation and data-driven feedback
Ability to initiate and assist Customer Service with Return Material Authorization (RMA) process
Experience developing re-inspection, sort, and/or rework instructions for Manufacturing Operators
Ability to collaborate with customers on issuing waiver or deviation documentation
Experience maintaining the Quality Management System (QMS)
Understanding of ISO 13485 Quality management systems requirements
Ability to ensure compliance with internal processes and requirements from certification bodies and regulatory agencies
Experience assisting in internal, 2nd party, and 3rd party audits
Ability to assist with responses and corrective actions for audit findings
Experience supporting Product Realization process
Ability to participate in design review, process planning, and failure mode analysis
Experience providing input on evaluation of Key Product Characteristics
Ability to provide input on gaging methods and equipment
Experience interpreting customer requirements including complex blueprints and GD&T call-outs
Ability to review and approve Engineering Change Notifications and Verifications
Experience evaluating for feasibility and implementing updates to customer requirements
Ability to incorporate industry standard best practices
Experience incorporating lessons learned
Ability to evaluate, submit and track Supplier Change Notices
Experience acting as Manufacturing point of contact for product quality related questions
Ability to approve Medical Device release for shipment
Experience performing batch record reviews for medical devices prior to release for shipment
Ability to generate Certificate of Analysis
Experience releasing product in ERP system based on customer and process requirements
Ability to support Manufacturing process
Experience training Manufacturing and Quality Control personnel on customer requirements
Ability to manage product inspection and testing activities
Experience obtaining customer approvals for required changes based on Quality Agreements
Ability to compile supporting measurement and process performance data
Experience assembling supporting documentation package and reviewing for completeness and accuracy
Ability to review and approve production documentation updates according to Engineering Change Order process
Company
Pivotal Solutions
Pivotal Solutions serves CIOs, CTOs, HR Directors and CFOs in a broad cross section of industries.
Founded in 2002
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase