Quality Engineer

Socket.dev; Dartmouth (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Tega Medical in Dartmouth, MA is seeking a Quality Engineer to lead quality and process engineering efforts, ensuring CFR 21 Part 820 FDA QSR, GMP, ISO 13485 compliance, and alignment with the company's quality vision.

You will partner with Quality, Operations, R&D and Supply Chain to investigate issues, drive CAPA, perform validations (IQ/OQ/PQ) and risk analyses, and support supplier quality improvements in a fast-paced manufacturing setting.

Qualifications

• ASQ CQE/CQA preferred.
• Lean Six Sigma training encouraged.
• Strong engineering/problem solving skills.
• Excellent written and oral communication.
• Understanding of GMP, FDA, SOP standards & regulatory requirements.
• Ability to work in fast-paced manufacturing while managing multiple projects.
• Knowledge of IQ/OQ/PQ/PPQ processes.
• Risk analysis techniques including PFMEA and Control Plans.
• Blueprint reading and GD&T proficiency.
• Hands-on experience in manufacturing: quality & process disciplines.

Responsibilities

• Develop and implement quality policies, initiatives, and procedures of the Quality Management System per CFR 21 Part 820, GMP and ISO 13485.
• Lead or support investigations into internal and supplier/external manufacturing quality issues to resolve complaints and CAPA.
• Prepare validation/qualification protocols and support IQ/OQ/PQ validations with suppliers and external manufacturers.
• Manage Supplier Change Notifications with suppliers and external manufacturers.
• Collaborate with Supply Chain, R&D, Operations Engineering, and Manufacturing to reduce process variability and implement improvements.
• Define and monitor KPIs to ensure process compliance and continuous improvement.
• Provide engineering support to define in-process and incoming inspection requirements.
• Evaluate process critical quality parameters and update specifications and protocols.
• Perform other duties as assigned by Supervisor.

Skills

ASQ CQE/CQA

Lean Six Sigma Green Belt

Lean Six Sigma Black Belt

Problem solving

Written and verbal communication

GMP FDA SOP compliance

Process validation & verification

Root cause analysis

Minitab

MS Office

Education

BS in Engineering

Associates degree in engineering

Tools

Minitab

Blueprints & GD&T

CAPA systems

MS Office

Job description

Job Summary

The Quality Engineer leads and uses Quality & Process Engineering principles, tools and practices to develop and optimize systems, and ensure processes are aligned with the overall business and quality vision of Tegra Medical. The individual must be capable of working independently and in a team setting supporting the Quality and Operations groups.

Role and Responsibilities

• Develop and implement company quality policies, initiatives, and procedures of the Quality Management System and ensure compliance with US – CFR 21 part 820 (FDA QSR, GMP), ISO 13485.
• Lead or support teams to investigate internal, supplier / external manufacturing quality issues (Failure investigations) to resolve complaints, non-conforming products and CAPA.
• Lead the preparation of validation and qualification protocols and support the execution of supplier and external manufacturing process /product qualifications & validations (IQ, OQ, PQ) projects.
• Management of Supplier Change Notifications with suppliers and external manufacturers.
• Participate and collaborate with Supply chain, R&D Engineering, Operations Engineering and Manufacturing to identify potential areas of process variability, address root causes and implement improvements.
• Ensures appropriate metrics/ Key Performance Indicators are defined, measured and analyzed to ensure process compliance and continuous improvement opportunities and follow up of product performance.
• Provide or lead general engineering support to define in-process inspection & incoming inspection requirements.
• Evaluates process critical quality parameters and updates specifications and protocols.
• Additional duties and responsibilities as assigned by Supervisor.

Qualifications

• ASQ CQE/CQA Preferred
• Lean Six Sigma training (Green Belt and Black Belt) desired
• Strong engineering skills, problem analysis/solving.
• Excellent written and oral communication skills.
• Understanding of GMP, FDA and SOP standards, guidelines, and regulatory requirements.
• Ability to work in a fast paced manufacturing environment while managing multiple projects.
• Strong engineering skills with working knowledge of the following: Process validation and verification activities. (IQ, OQ, PQ, PPQ).
• Risk analysis techniques, which include PFMEA (Process Failure Modes and Effects Analysis). Manufacturing Control Plans and Flow Plans.
• Blue print & GD&T reading.
• Problem solving techniques including root cause analysis, and cause and effect analysis.
• Proficiency with Microsoft Office products (Word, Excel, Project, PowerPoint) and Minitab.
• Hands-on experience in the manufacturing, quality & process disciplines.

Education Requirements

A minimum B.S. in an engineering discipline or associates degree and equivalent experience of 5 years of in Quality Engineering.