Quality Engineer - New Venture

Position Summary

The Quality Engineer is responsible for overseeing the health of the manufacturing processes. This starts with proper risk analysis in manufacturing design, then goes into addressing risk in process validations, and continues with overseeing risk using statistical quality control during manufacturing. In addition, addressing known issues with a strong Corrective and Preventive Action system to ensure the root cause is identified and controlled. The Quality Engineer will work collaboratively with the Engineering and Production departments. A key part of success is ensuring that all departments and employees follow the standard operating procedures. To this extent, the Quality Engineer is empowered to monitor and report on procedural conformance within the company. The Quality Engineer will participate in Internal Audits as directed by the Quality Manager. In addition, the Quality Engineer will lead continuous improvement efforts following a structured methodology such as six sigma. Key metrics: First Pass Yield, Scrap, number of repeat CAPAs, CAPA On Time, and Validation on Time.

Job Responsibilities

• Change Management – evaluate the impact to product, processes, and equipment changes on critical attributes and quality architectures.
• Commissioning, Qualification and Validation - provide Quality support and oversight for commissioning, qualification and validation of new and existing processes.
• Quality by Design (QbD) – participate in the definition of user requirements and ensure they conform with company processes and regulatory guidance.
• Critical process parameter (CPP/CQA) – assure CPP/CQAs are defined and understood by engineering and incorporated into design and control functions.
• Risk Management – assures risk management decisions are done in a disciplined manner to document decisions and rationale.
• Data Integrity – ensure GMP data captured and managed by engineering and production are handled, stored and maintained in accordance with procedures.
• Audits - represent the company during contact with the FDA and other regulatory agency audits. Serve as an Internal Auditor.
• Data Management- perform statistical data analysis and prepare reports.
• pFMEA- facilitate team exercises to evaluate and identify potential failures modes, risk, and opportunities related to operational processes, and develop control plans.
• CAPA – lead corrective and preventive actions resulting from known issues and continuous improvement opportunities.
• Other duties as assigned by management

Experience Requirements

• Must possess strong knowledge manufacturing within a regulated industry such as medical device, automotive, or defense.
• Must be detail-oriented with exceptional planning and organizational skills.
• Must be an effective communicator both up and down the organizational structure.
• Mentoring and training new employees is an essential skill for this position.
• Strong competency in medical validation practices. Automotive PPAP process is also considered.
• Six Sigma certification preferred
• Minimum 3 years’ experience working in GMP manufacturing and/or engineering environment required.
• Must be able to sit and/or stand for extended periods of time,
• Must be able to climb stairs, must be able to lift and carry 25 lbs., and walk while carrying items.

 Education Requirements 

• Bachelor's degree in a scientific discipline or related field. In rare instances, a combination of education and relevant work experience may be acceptable in lieu of a Batchelor’s degree.

 EOE, including disability/vets