Quality Engineer with ISO 13485

Quality Engineer

Work Schedule: Monday – Friday 7:00 AM – 4:00 PM

Full Time

POSITION SUMMARY: The Quality Engineer leads and uses Quality and Process Engineering principles, tools and practices to develop and optimize systems and ensure processes are aligned with the overall business and quality vision. This individual will also collaborate with cross-functional teams, implement process improvement initiatives, and contribute to the overall success of the client.

Essential Duties And Responsibilities

• Develop and implement company quality policies, initiatives, and procedures of the Quality Management System and ensure compliance with ISO 13485.
• Ensure appropriate metrics/ Key Performance Indicators are defined, measured, and analyzed to ensure process compliance, continuous improvement opportunities and follow-up of product performance.
• Provide or lead general engineering support to define in-process inspection & incoming inspection requirements.
• Evaluate process critical quality parameters and update specifications and protocols.
• Participate in cross-functional teams to drive root cause analysis, corrective actions, and preventive measures.
• Quality and Production Planning to maximize reliable quality outcomes and efficiency.
• Make recommendations for replacing production equipment and process monitoring devices before the end of their lifecycle.
• Identify and help specify new production equipment and monitoring devices.
• Execute regular, timely production monitoring activities per customer contract and best practices based on work performed.
• Ensure that the production monitoring plan is maintained as contracted, per best practices, and consistently documented.
• Ensure proper documentation for all maintenance, production, and quality procedures are complete and verified as regulatory requirements and company policy require.
• Qualify the company to work on new business.
• Qualify company to work with new customers by building process control plans and participating in customer meetings.
• Confirm all finishing, material removal, and documentation requirements of new projects.
• Create/maintain PFMEAs and perform risk assessments prior to deploying new products or processes.
• Build internal and external validation of processes (IQ, OQ, PQ) to demonstrate the ability of stated processes to achieve planned results.
• Collaborate with maintenance, production, and quality assurance teams to develop and implement standard operating procedures (SOPs) and work instructions.
• Perform process capability studies, statistical analysis, and data-driven decision-making to achieve operational excellence and meet production targets.
• Ensure compliance with safety, environmental, and regulatory requirements in all process engineering activities.
• Lead process validation activities, including protocol development, execution, and documentation, ensuring compliance with regulatory requirements.
• Provide training and guidance to other departments on new processes, procedures, and equipment to ensure successful implementation and operation.
• Stay up to date with the latest advancements in process engineering technologies, methodologies, and best practices.
• Foster company-wide teamwork and commitment through written and verbal communication and relationship-building.
  
  

Skills

• Strong knowledge of chemical engineering principles (e.g., mass transfer, thermodynamics).
• Understanding of how metals react to electropolishing, and the different electrolytes used (e.g., phosphoric acid, sulfuric acid).
• Knowledge of metal finishing industry standards (e.g., ASTM B912, ASTM A967)
• Excellent problem-solving and analytical skills with the ability to identify and resolve complex process issues.
• Working knowledge of process safety, risk assessment, and compliance with regulatory standards.
• This includes knowledge of environmental and safety regulations (e.g., OSHA).
• Strong project management skills with the ability to prioritize tasks and meet deadlines.
• Considers urgency and importance when making decisions.
• Ability to accurately read and interpret engineering drawings, a variety of instructions furnished in written, oral diagram, or schedule form.
• Data analysis and statistical process control (SPC) skills, experience using software like Minitab.
• Experience optimizing processes for efficiency and quality using tools like Six Sigma or Lean methodologies.
• Ability to troubleshoot equipment problems (e.g., rectifiers, pumps, filters).
• Conscientious and responsible in a team environment, collaborating well with all employees of the company.
• This includes the ability to communicate effectively with supervisors, managers, and co-workers in a fast-paced production environment.
• Excellent problem-solving and written communication skills to collaborate with internal and external teams and present findings (e.g., PDCA, DMAIC, Kaizen).
• Ability to communicate effectively and respectfully to customers and external auditors in writing and in person.
• Computer skills in MS Office, presentation development, and digital photography.
  
  

Qualifications

• Must have metals experience, prefer metal finishing experience.
• 5 years of experience as a Quality Engineer in a manufacturing environment required.
• Experience with electropolishing or similar electrochemical processes (e.g., electroplating, anodizing) is strongly preferred.
• Needs working knowledge of ISO 9001, strongly prefer experience with ISO 13485.
• BS degree in supporting discipline is strongly preferred, but not required.
• Degree in chemical engineering, materials science, or related field preferred.
• Certifications in Six Sigma or Lean Manufacturing preferred.
  
  

PHYSICAL DEMANDS: While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, feel; reach with hands and arms, and talk or hear. The employee is occasionally required to climb, balance, stoop, kneel, crouch, and crawl. The employee must frequently lift and/or move up to 30 pounds without assistance, and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision (must be able to see green), peripheral vision, depth perception and the ability to adjust focus. This position requires a minimum of 20:20 vision with or without corrective lenses.

WORK ENVIRONMENT: While performing the duties of this job, the employee is exposed to toxic or caustic chemicals. The employee is occasionally exposed to high, precarious places, fumes, airborne particles, and vibration. The noise level in the work environment is usually moderate.

Benefits

• Health Insurance
• Vacation
• 401(k) with employer contribution
• Discretionary year-end bonus
• Life Insurance
• Short Term Disability
• Voluntary dental and vision insurance
  
  

Skills: quality engineer,risk assessment,metal finishing industry standards,regulatory requirements,equipment troubleshooting,project management,lean methodologies,project management skills,problem-solving,metals,six sigma,process safety,ms office proficiency,ms office,troubleshooting equipment,electropolishing,six sigma methodologies,statistical process control (spc),problem-solving skills,communication skills,chemical engineering principles,regulatory compliance,process safety knowledge,data analysis,analytical skills