Job Title: Quality Engineer - NPI

For immediate consideration, please apply directly to this job posting AND email me at biacosta @actalentservices.comwith the following:

1) Word copy of resume

2) 2-3 professional references

3) 4-5 brief bullet points highlighting technical qualifications

Job Description

In this role, you will lead the design for manufacture and assembly by providing technical leadership and guidance in quality assurance, quality control, and preventative activities. You will support the development and introduction of new products, processes, and technologies with a focus on quality systems development, regulatory compliance, and process risk management. Your role involves developing and characterizing processes that are capable, scalable, and produce high yield, while also designing robust inspection strategies.

Responsibilities

• Foster collaborative internal and external professional relationships across design divisions and functions related to design transfer activities.
• Communicate effectively with internal customers, stakeholders, and project teams to ensure successful project transfers.
• Mentor other groups on design and process transfer expertise.
• Develop and implement methods for process control and improvement to ensure product quality.
• Collaborate with suppliers to address quality issues and contribute to supplier quality improvement programs.
• Manage risk by employing risk management practices and tools, with a focus on failure modes and process controls.
• Ensure compliance with ISO14971 standards and support the design team in risk identification and mitigation.
• Develop and implement lean inspection strategies and lead continuous improvements in inspection methods.
• Lead and approve validation strategies and influence processes towards validation.
• Apply statistical techniques to develop robust quality systems and provide expertise for non-conformances and corrective actions.
• Lead supplier qualification strategies and support the implementation of supplier certification.
• Represent quality assurance in design transfer processes and ensure product launches meet established targets.

Essential Skills

• Proficiency in risk management and PFMEA
• Experience with validation and quality engineering in medical devices
• Knowledge of ISO14971 and design transfer processes
• Bachelor of Science in Engineering or related field with 3-5 years of experience in a quality or technical discipline

Additional Skills & Qualifications

• Experience in developing inspection strategies and using measurement system analysis (MSA)
• Knowledge in CQA and CTQ processes
• Ability to overhaul production processes and align procedures

Work Environment

This position requires working onsite. The role is an individual contributor position that requires independent work with minimal supervision. Standard benefits are offered, including 2 weeks of PTO and 10 paid holidays.