Quality Engineer II

JOB PURPOSE:

The Quality Engineer II is responsible for supporting process improvements, risk management activities, complaint process, design control activities, customer/ISO/FDA audits and non-conforming material as it relates to sustaining products.  

The Quality Engineer II participates in review and approval of Quality System documents, resolves quality issues and ensure quality control of products and processes, in compliance with all applicable company policies and procedures.

ESSENTIAL DUTIES:

• Follows all Quality System requirements and company procedures ensuring regulatory requirements are met in an ethical manner.
• Meets commitments on time with accuracy and attention to detail.
• Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Develop validation and/or verification protocols for changes related to process improvements; execute validations/verifications and report on the conclusions to support process improvements.
• Quality Representative for process and software validations (may require writing, reviewing, executing, analyzing and/or reporting on test protocols).
• Maintains a working knowledge of applicable statistical techniques for validation and process capability/performance purposes.
• Quality Representative for Risk Management Activities for existing products.
• Provide interpretive assistance, to all departments, regarding quality documents.
• Support training on Manufacturing and Quality System documents. 
• Conduct customer complaint investigations, interface with customers to gather necessary details,  determine root cause and implement corrective and preventive actions.
• Interface with Engineering to drive continual improvement on existing manufacturing processes.
• Quality Representative for Design Control Activities for existing product lines.
• Release documents via the change control process as necessary.  Train others where required.
• Prepare quality related deliverables in a timely manner.
• Participate in CAPA root cause investigation and actions implementation.
• Implement ongoing quality improvement processes working with cross functional teams.
  Acts as a consultant for areas related to his/her expertise.
• Performs other related duties as assigned by management.
• Quality Representative for contract review activities on existing products.
• Provides support as the primary Quality representative for Notices of Change (NOCs), Notices of Activity (NOAs), and Nonconforming Material Reports (NCRs) related to existing products.
• Potential Quality System Process Owner for the following (but not limited to):
  • Non-conforming Reports (NCR)
  • Customer Complaints
  • Supplier Quality
  • Environmental Monitoring
  • Corrective and Preventive Actions (CAPA)
  • Internal Audits
  • Training

QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)
Required: 
3 to 8 years of relatable experience in a regulated industry is required.
A Bachelor's degree in engineering or related discipline is required; it may substitute for some of the years of required experience and knowledge.
•    Well-rounded knowledge of ISO 13485:2016 and FDA QSR.
•    Strong root-cause investigator and problem solver within a manufacturing environment.
•    Mechanical aptitude with manufacturing experience.
•    Well-developed written and verbal communication skills.  Ability to write and comprehend instructions, short correspondence, and memos.  
•    Must possess the ability to work semi-independently with little daily input from a manager.
•    Experienced in statistical analysis.
•    Certified Lead Auditor
•    Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form.  
•    Well versed in data management and graphical presentation of data.
•    Experienced with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required.
•    Generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users in the organization.
Preferred:
•    Previous experience in manufacturing environment in technical support role
•    Competency with Lean Manufacturing principles

WORKING CONDITIONS: 
Works under general supervision. Requires light physical activity performing non-strenuous daily activities.