Quality Auditor - Medical Device Job at SQA Services (Minneapolis-St. Paul, MN)

Principal Supplier Quality Engineer

This position provides technical leadership for Supplier Quality Management proc...

Location

United States

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills and experience.
B.S. in Engineering, Science, Business, or another relevant field
Minimum of 10 years of collective experience in a Research, Manufacturing, Quality and/or Regulatory Affairs function within a medical device, pharmaceutical, biologic, or other highly regulated industry.
Supplier Quality Engineering experience in the Medical Device industry
Strong understanding of Risk Management principles and techniques.
Knowledge of Statistical Techniques
Experience in root cause analysis and failure investigation tools
Working knowledge of the MDSAP Single Audit program including the regulations for US, Japan, Canada, Australia, and Brazil
Working knowledge of the key medical device compliance related standards such as ISO 13485, ISO 14971, ISO 19011, ISO 10993, etc.
Certification as CQA, CBA, MDA, or ISO 13485 Lead Auditor

Job Responsibility

Ensure conformance to industry practices, domestic and international regulatory requirements and established company procedures.
Provide global technical leadership in the development and implementation of quality and regulatory compliance strategies and best practices to ensure the manufacturing and distribution of products comply with applicable regulatory requirements.
Lead cross-functional collaboration with Procurement, R&D/Operations, Technical Quality, and Logistics teams to address quality issues at contract manufacturers and suppliers.
Establish and administer the supplier audit program for quality/regulatory compliance.
Maintain the Approved Supplier List (ASL).
Support the Global Supplier Review Board, including providing metrics for supplier assessments.
Actively engage with suppliers in the event of a supplier issue requiring corrective action or upcoming external audits.
Provide guidance as needed for corrective action required because of assessment findings.
Execute supplier audits in accordance with approved schedules.
Support documentation of supplier changes through the supplier notification, change management, QNC, or CAPA processes.

What we offer

comprehensive and competitive range of benefits
Total Rewards package
pay
health care benefits
retirement plans
work/life benefits
generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
benefits on day 1
free onsite gym
onsite cafeteria

Principal Supplier Quality Engineer

This position provides technical leadership for Supplier Quality Management proc...

Location

United States , Alpharetta

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

B.S. in Engineering, Science, Business, or another relevant field
Minimum of 10 years of collective experience in a Research, Manufacturing, Quality and/or Regulatory Affairs function within a medical device, pharmaceutical, biologic, or other highly regulated industry
Supplier Quality Engineering experience in the Medical Device industry
Strong understanding of Risk Management principles and techniques
Knowledge of Statistical Techniques
Experience in root cause analysis and failure investigation tools
Working knowledge of the MDSAP Single Audit program including the regulations for US, Japan, Canada, Australia, and Brazil
Working knowledge of the key medical device compliance related standards such as ISO 13485, ISO 14971, ISO 19011, ISO 10993, etc.
Certification as CQA, CBA, MDA, or ISO 13485 Lead Auditor
Strong project management skills

Job Responsibility

Ensure conformance to industry practices, domestic and international regulatory requirements and established company procedures
Provide technical leadership for Supplier Quality Management processes and activities
Implement, coordinate, support, and monitor activities related to the Global Supplier Quality Management (SQM) activities across Avanos
Train R&D, Technical Quality, Operations, and other functions on the established processes
Provide global technical leadership in the development and implementation of quality and regulatory compliance strategies and best practices
Lead cross-functional collaboration with Procurement, R&D/Operations, Technical Quality, and Logistics teams to address quality issues at contract manufacturers and suppliers
Establish and administer the supplier audit program for quality/regulatory compliance
Maintain the Approved Supplier List (ASL)
Support the Global Supplier Review Board, including providing metrics for supplier assessments
Actively engage with suppliers in the event of a supplier issue requiring corrective action or upcoming external audits

What we offer

comprehensive and competitive range of benefits
Total Rewards package
health care benefits
retirement plans
work/life benefits
generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
benefits on day 1
free onsite gym
onsite cafeteria
uncapped sales commissions

Fulltime

Supplier Development Engineer

We are seeking a Supplier Development Engineer to help scale our supply chain to...

Location

United States , Hayward

Salary:

133000.00 - 195000.00 USD / Year

1X Technologies

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Mechanical, Industrial, or a related engineering field
6+ years of experience in quality, supplier quality, or manufacturing—ideally in automotive, aerospace, or medical devices
Hands-on experience launching new products and improving quality systems
Skilled in problem-solving methods like Six Sigma, 8D, and root cause analysis
Proficiency with quality tools such as FMEAs, control plans, SPC, MSA, and capability studies
Understanding of manufacturing processes related to electronics, batteries, and precision sensors
Strong experience with supplier audits, APQP, PPAP, and production ramp-ups
Ability to read engineering drawings and use GD&T
knowledge of ISO 9000 and IATF 16949 quality systems
Certifications like CQE, Six Sigma Green Belt, or Quality Auditor are a plus

Job Responsibility

Partner with engineering and sourcing teams to select suppliers based on capabilities in castings, machining, and structural assembly
Source and qualify vendors for castings, extrusions, machined parts, and sheet metal
Validate surface treatments, welding, heat treatments, and coating processes
Review GD&T on complex structural components and verify with metrology tools
Collaborate on lightweighting initiatives and design optimizations
Lead the supplier industrialization process from design through production ramp-up
Support suppliers with tooling, equipment, and process qualifications
Assess supplier readiness for vehicle builds and manage production risk
Drive the APQP process and support PPAP through the start of production
Train suppliers on 1X’s quality systems and review part quality documentation

What we offer

Health, dental, and vision insurance
401(k) with company match
Paid time off and holidays

Fulltime

Supplier Development Engineer

We are seeking a Supplier Development Engineer to lead supplier qualification an...

Location

United States , Hayward

Salary:

133000.00 - 195000.00 USD / Year

1X Technologies

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Mechanical, Industrial, or a related engineering field
6+ years of experience in quality, supplier quality, or manufacturing—ideally in automotive, aerospace, or medical devices
Hands-on experience launching new products and improving quality systems
Skilled in problem-solving methods like Six Sigma, 8D, and root cause analysis
Proficiency with quality tools such as FMEAs, control plans, SPC, MSA, and capability studies
Understanding of manufacturing processes related to electronics, batteries, and precision sensors
Strong experience with supplier audits, APQP, PPAP, and production ramp-ups
Ability to read engineering drawings and use GD&T
knowledge of ISO 9000 and IATF 16949 quality systems
Certifications like CQE, Six Sigma Green Belt, or Quality Auditor are a plus

Job Responsibility

Partner with engineering and sourcing teams to select suppliers based on manufacturing capabilities for EEE components, connectors, battery cells, and sensors
Collaborate with suppliers on design reviews to ensure manufacturability and explore new production techniques
Lead the supplier industrialization process from design through production ramp-up
Support suppliers with tooling, equipment, and process qualifications
Assess supplier readiness for vehicle builds and manage production risk
Drive the APQP process and support PPAP through the start of production
Train suppliers on 1X’s quality systems and review part quality documentation
Lead root cause and corrective action efforts for supplier quality issues
Monitor and report supplier quality metrics to ensure ongoing improvement
Apply lean and quality tools to drive continuous improvement across the supply base

What we offer

Health, dental, and vision insurance
401(k) with company match
Paid time off and holidays

Fulltime

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