Sr. Quality Engineer

Avalign Technologies Inc; Warsaw (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Avalign Technologies Inc. is seeking a Quality Engineer to support manufacturing quality and production goals. You will lead inspection plan development, assist with validation, CAPA investigations, and supplier quality management, while ensuring compliance with FDA QSR and ISO 13485.

Responsibilities include audits, non-conformance handling, risk management, and continuous improvement across processes and products. A BS in engineering and 5+ years in manufacturing are preferred.

Qualifications

• BS in engineering or engineering science with ≥5 years manufacturing experience
• New production introduction or process development experience preferred
• Familiarity with ISO 13485 and 21 CFR 820 regulatory requirements
• Ability to read blueprints and knowledge of GD&T and inspection methods
• Skilled in statistical analysis and problem solving to determine product acceptance and evaluate process capabilities

Responsibilities

• Provides quality leadership in manufacturing inspection plan development.
• Leads validation planning and NPI transfer activities.
• Supports CAPA investigations and design changes.
• Primary quality representative for site supplier management and resolution of supplier nonconformances.
• Supports internal and external audits to maintain regulatory, customer and Avalign compliance.
• Manages Non-Conforming Material Reports system and dispositions all non-conforming product.
• Enhances and drives product risk management activities and mitigations.
• Participates in technical discussions and risk-based decision making.
• Identifies opportunities and recommends improvements to quality system and manufacturing processes; drives continuous improvement.
• Establishes effective corrective action plans and leads implementation of quality assurance plans and CAPA systems.
• Recommends test methods and SPC procedures for product reliability.
• Conducts or guides testing and data analysis to demonstrate that new processes meet acceptance criteria, including capability studies and Gage R&R studies.
• Acts as main Quality Engineering contact for assigned customers and projects.
• May supervise quality technicians and/or inspectors as needed at the manufacturing facility.
• Ensures compliance with Avalign procedures, customer requirements; and industry regulations including FDA QSR and ISO 13485.
• Supports materials review board process and risk management in operations.
• Provides ongoing quality engineering support to operations including investigation and documentation.

Skills

Quality leadership

Validation planning

CAPA investigations

Risk management

Gage R&R

Statistical analysis

Continuous improvement

Education

BS in engineering/engineering science

Job description

The Quality Engineer is responsible for supporting the organization to ensure quality and production goals are met. The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and ensure quality standards of all products are met.

What You’ll Do:

• Provides quality leadership in manufacturing inspection plan development.
• Provides leadership to engineering and manufacturing functions for validation planning and NPI transfer activities. Assists teams in determining validation needs and requirements.
• Provides ongoing quality engineering support throughout the product life cycle, including CAPA investigations, and design changes.
• Primary quality representative for site supplier management and resolution of supplier nonconformances
• Support internal and external audits to maintain regulatory, customer and Avalign compliance.
• Manages Non-Conforming Material Reports system and dispositions all non-conforming product.
• Enhances and drives product risk management activities. Ensures identified activities and mitigations are executed.
• Participates in technical discussions and risk-based decision making.
• Identifies opportunities and recommends improvements to quality system and manufacturing processes; drives continuous improvement.
• Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Recommends test methods and statistical process control procedures for achieving required levels of product reliability.
• Conducts or guides testing and data analysis which demonstrate that new processes meet acceptance criteria, including capability studies and Gage R&R studies.
• Acts as main Quality Engineering contact for assigned customers and projects.
• May supervise quality technicians and/or inspectors as needed at the manufacturing facility.
• Serves as a quality representative to assigned manufacturing areas and/or customers. Responsible for ensuring compliance with Avalign procedures, customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485.
• Supports operations and engineering teams to ensure the Material Review Board process is followed.
• Provides ongoing quality engineering support to operations, including risk management, developing appropriate inspection requirements; and complaint/NC/CAPA investigations.
• Submit documentation to customers for new product launches and legacy product documentation requests.

Competencies/Essential Functions:

To perform the job successfully, an individual should demonstrate the following:

• Leads assigned team in the development of quality related processes & initiatives.
• Monitor complaint trends and data in order to escalate emerging issues appropriately.
• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements

What You’ll Need:

• Candidates should have a BS in an engineering science plus at least 5 years of manufacturing experience, or an equivalent combination of education and experience.
• New production introduction/process development experience in a manufacturing environment highly preferred.
• An understanding of quality standards (ISO 13485) & regulatory requirements (21CFR820).
• Ability to read and interpret blueprints as well as have a Knowledge of GD&T, and Inspection methods.
• Ability to utilize statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.