Quality Engineer

JOB SUMMARY:

This role is responsible for executing quality engineering activities. The position ensures that products meet internal specifications customer requirements and regulatory standards through robust inspection process control and quality system oversight. The individual will lead problem-solving efforts manage QC operations and support continuous improvement initiatives across manufacturing.

QUALITY ENGINEERING DUTIES:

• Participate in validations (IQ/OQ/PQ) and process qualifications
• Conduct capability studies SPC monitoring and data analysis to identify trends and improvement opportunities
• Develop control plans perform risk analysis FMEAs inspection instructions and gage control practices (calibration R&R / TMV).
• Investigate production quality issues perform root cause analysis and coordinate corrective actions
• Lead and maintain change control efforts
• Conduct layered process audits and support internal/external audits
• Develop manage and improve the facilitys Quality Management System ensuring compliance with ISO 9001 or customer-specific standards.
• Maintain and update quality assurance procedures documentation and inspection standards for injection molding operations
• Implement proactive and reactive quality measures to reduce defects improve process efficiency and control variation
• Serve as the main point of contact for customer quality issues
• Manage customer complaints documentation and resolution activities
• Train mentor and support quality and production staff to ensure understanding of standards inspection methods and best practices

QUALIFICATIONS (Education/Experience/Knowledge Skills & Abilities)

• Bachelors Degree or equivalent or 3-5 years related experience and/or training or equivalent combination of education and experience in quality engineering in the medical industry
• Experience working in regulated manufacturing environments
• Knowledge of cleanroom practices
• Strong understanding of regulatory requirements and industry standards (e.g. FDA QMSR ISO 9001).
• Thorough knowledge of quality management systems material inspection methods and rootcause analysis/problemsolving tools.
• Proficiency in GD&T interpretation statistical analysis and sampling techniques.
• Skilled in the use of measurement tools including calipers micrometers vision systems and CMMs.
• Strong working knowledge of PPAP FMEA control plans SPC and CAPA documentation and processes.
• Experience leading or contributing to CAPA investigations and corrective action activities.
• Ability to work with a high volume of documents in a fast-paced environment
• Ability to communicate effectively with all levels of staff and management both internal and external
• Strong leadership communication and analytical skills
• Collaborate with cross-functional teams
• Strong Computer skills; Microsoft Office (Word Excel) and Minitab

WORKING CONDITIONS:

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

• Must be able to lift up to 25 lbs.
• Must be able to sit or stand for long periods of time
• Must be able to climb up and down stairs
• Travel is required to support company initiatives

NOTE: This job description is not intended to be an exhaustive list of all possible duties responsibilities and or qualifications. Other duties responsibilities and/or qualifications may be assigned to this position.