Medix™
This range is provided by Medix™. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $95,000.00/yr - $120,000.00/yr
Direct message the job poster from Medix™
The Senior Quality Engineer plays a critical role in ensuring that all products meet customer requirements and quality standards. This position is responsible for providing technical quality support throughout the product lifecycle, from development to manufacturing. The Senior Quality Engineer will collaborate with cross‑functional teams, including Engineering, Operations, and Sales, to manage quality systems, address nonconformances, and drive continuous improvement.
Key Responsibilities
Lead and support
qualification and validation activities for new and existing manufacturing processes.
Champion and process
non-conformance events, customer complaints, and related
Corrective and Preventive Actions (CAPA) .
Provide technical expertise
to ensure effective supplier control and integrity of outsourced services.
Oversee and supervise
the QC/QA inspection team, ensuring high-quality processing performance and product output.
Support
the transition of manufacturing processes and related documentation from prototype to commercial production.
Promote and enforce
Quality Management System (QMS)
policies,
Good Manufacturing Practices (GMP) , and
Good Documentation Practices (GDP)
across the organization.
Contribute to and lead
internal and external audit activities.
Drive key quality objectives
on the production floor, including in‑line inspections, lean manufacturing initiatives, and achieving throughput and scrap goals.
Support
purchasing and receiving inspection to ensure the accuracy and timeliness of raw materials.
Required Skills & Experience
5-8 years of experience
in an ISO/FDA-regulated medical manufacturing environment.
Bachelor’s Degree
in Engineering, Science, Manufacturing, or a related field, or equivalent practical experience.
Demonstrated skills
in root-cause analysis, Statistical Process Control (SPC), equipment and process qualification, metrology, and auditing.
Strong communication skills
and a collaborative, team-oriented mindset.
Proficiency
with relevant business and quality software applications.
Preferred Skills & Experience
Experience with
Class II or Class III medical devices
and contract manufacturing.
Experience with
extrusion processes
is highly preferred.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Medix™ by 2x
#J-18808-Ljbffr
Base pay range $95,000.00/yr - $120,000.00/yr
Direct message the job poster from Medix™
The Senior Quality Engineer plays a critical role in ensuring that all products meet customer requirements and quality standards. This position is responsible for providing technical quality support throughout the product lifecycle, from development to manufacturing. The Senior Quality Engineer will collaborate with cross‑functional teams, including Engineering, Operations, and Sales, to manage quality systems, address nonconformances, and drive continuous improvement.
Key Responsibilities
Lead and support
qualification and validation activities for new and existing manufacturing processes.
Champion and process
non-conformance events, customer complaints, and related
Corrective and Preventive Actions (CAPA) .
Provide technical expertise
to ensure effective supplier control and integrity of outsourced services.
Oversee and supervise
the QC/QA inspection team, ensuring high-quality processing performance and product output.
Support
the transition of manufacturing processes and related documentation from prototype to commercial production.
Promote and enforce
Quality Management System (QMS)
policies,
Good Manufacturing Practices (GMP) , and
Good Documentation Practices (GDP)
across the organization.
Contribute to and lead
internal and external audit activities.
Drive key quality objectives
on the production floor, including in‑line inspections, lean manufacturing initiatives, and achieving throughput and scrap goals.
Support
purchasing and receiving inspection to ensure the accuracy and timeliness of raw materials.
Required Skills & Experience
5-8 years of experience
in an ISO/FDA-regulated medical manufacturing environment.
Bachelor’s Degree
in Engineering, Science, Manufacturing, or a related field, or equivalent practical experience.
Demonstrated skills
in root-cause analysis, Statistical Process Control (SPC), equipment and process qualification, metrology, and auditing.
Strong communication skills
and a collaborative, team-oriented mindset.
Proficiency
with relevant business and quality software applications.
Preferred Skills & Experience
Experience with
Class II or Class III medical devices
and contract manufacturing.
Experience with
extrusion processes
is highly preferred.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Medix™ by 2x
#J-18808-Ljbffr