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 facility\'s 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 **EXPERIENCE, SKILLS,

EDUCATION AND TRAINING: QUALIFICATIONS (Education/Experience/Knowledge,

Skills & Abilities)** - Bachelor\'s 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 root-cause analysis/problem-solving 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.**