Top 217 Medical device quality engineer Jobs in Austin, Tx

Quality Systems Engineer (Medical Device)
Noramtec Consultants Americas —Austin, TX
- $54 - $57 an hour
- Full-time
- Hybrid work
- Background check
- Engineering
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Staff Quality Engineer
Nuclein —Austin, TX
- Full-time
- Management
- Bachelor of Science
- Travel
5d
Quality Engineer
Fab2 —Austin, TX
- Full-time
- CAD
- Mid-level
- Commuter assistance
- Paid parental leave
Product Quality & Reliability Engineer
Advanced Micro Devices, Inc —Austin, TX
- Hybrid work
- Bachelor of Science
- Assembly
- Doctor of Philosophy
Quality Engineer II
Thermo Fisher Scientific —Austin, TX
- Full-time
- Background check
- Pass drug screening
- No experience needed
4d
Senior Wire Harness Design Engineer (EWIS)
Saronic Technologies —Austin, TX
- Full-time
- Office
- Mentoring
- Senior level
- Paid parental leave
- Paid holidays
Quick Apply
Manufacturing Engineer - Wire Harnessing
Saronic Technologies —Austin, TX
- Full-time
- Mid-level
- Analysis skills
- 1 year
- Paid parental leave
- Paid holidays
Quick Apply
Senior Equipment Engineer
SkyWater Technology Foundry, Inc. —Austin, TX
- Full-time
- Engineering
- Senior level
- Communication skills
- Paid holidays
- Disability insurance
Quick Apply
Welding Engineer - 182364
Raise —Austin, TX
- $45 - $65 an hour
- Contract
- Hybrid work
- Background check
- ERP systems
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Quality Systems Engineer III
Aequor Technologies LLC —Austin, TX
- Contract
- 5 years
- Engineering
- Office
Quick Apply
Senior Quality Engineer
DiaSorin —Austin, TX
- Full-time
- Background check
- Pass drug screening
- Bachelor's degree
Manufacturing Quality Engineer (MQE) - iPhone
Apple —Austin, TX
- 5 years
- Bachelor of Science
- Analysis skills
Custom Timing and Verification CAD Engineer
Apple —Austin, TX
- $129,300 - $194,700 a year
- Computer science
- Computer Science
- Bachelor of Science
- Employee stock purchase plan
- Health insurance
Quality Systems Engineer
Neuralink —Austin, TX
- $71,000 - $119,000 a year
- Full-time
- Computer science
- Computer Science
- Mid-level
- Commuter assistance
- Paid holidays
Quality Engineer
Flex LTD —Austin, TX
- Full-time
- Analysis skills
- Bachelor's degree
- Team management
- Disability insurance
- Health insurance
Sr Product Quality Engineer - Onsite
Siemens Healthineers —Austin, TX
- $112,420 - $154,572 a year
- Full-time
- Engineering
- Master's degree
- Experience equivalent to degree accepted
- Disability insurance
- Health insurance
Quality Engineer, Optimus
Tesla —Austin, TX
- Full-time
- Mid-level
- 3 years
- SQL
- Commuter assistance
- Health savings account
Digital Design Engineer I
Silicon Labs Careers —Austin, TX
- $78,750 - $146,250 a year
- Full-time
- Hybrid work
- Master's degree
- Analysis skills
- Doctor of Philosophy
- Free parking
- Commuter assistance
CPU Core Design Verification Engineer
Advanced Micro Devices, Inc —Austin, TX
- Hybrid work
- Master's degree
- C++
- Senior level
Associate Controls Engineer
Tesla —Austin, TX
- Full-time
- Mid-level
- 1 year
- Communication skills
- Commuter assistance
- Health savings account
10d

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medical device quality engineer jobs near austin, tx

Quality Systems Engineer (Medical Device)

Noramtec Consultants Americas -
Austin, TX

Quick Apply

Job Details

Full-time | Contract
$54 - $57 an hour

Benefits

Health insurance
Dental insurance
401(k)
Vision insurance

Qualifications

Teamwork
Regulatory compliance
Statistical Process Control
Corrective and preventive actions (CAPA)
Microsoft Office
High school diploma or GED
Bachelor's degree
Biomedical regulatory compliance
Productivity software
ISO 13485
Certified Quality Engineer
FDA regulations

Full Job Description

Our client is a global leader in musculoskeletal healthcare. They design, manufacture and market orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products. Their products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Alongside some of the world's top healthcare professionals, they help deliver new possibilities to patients.

Looking for a candidate who has focused on design quality or with SaMD (Software as a medical device) related quality roles.

Job description

Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS).

The position is responsible for supporting the global development, implementation, and continuous improvement and harmonization of the local Quality Management System (QMS) in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR as well as corporate procedures and requirements.

What You Can Expect How You'll Create Impact Principal Duties and Responsibilities

Support cross-functional teams in the harmonization and standardization of quality procedures, tools, and best practices across sites and regions.

Complete gap assessments for local procedures against corporate procedures, requirements and applicable medical device regulations and standards.

Collaborate with cross functional team members to align & execute updates to local procedures to align with applicable requirements. This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Skills:

What Makes You Stand Out Expected Areas of Competence (i.e., knowledge, skills and abilities)

Extensive knowledge of global regulatory requirements for medical devices, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.

Skilled in developing and implementing procedures for various QMS elements including but not limited to purchasing controls, design controls, nonconformance management, validation, and corrective and preventive actions (CAPA).

Familiarity with quality tools and methodologies (e.g., Six Sigma, root cause analysis, risk management, SPC, FMEA).

Strong communication and collaboration skills, with the ability to influence and drive alignment across diverse stakeholders (R&D and Regulatory).

Preferred experience with enterprise quality systems and ERP systems (e.g., SAP, EtQ). Must have previous Medical Device Experience.

Preferred experience with SaMD (Software as a medical device) and class II medical devices.

Education:

High school diploma or equivalent required. Bachelor’s degree in Engineering preferred. Technical, engineering, and/or scientific background is strongly preferred.

Minimum 5+ years of experience in Quality/Regulatory Compliance or related field required CQE or equivalent certification preferred.

Must be familiar with Microsoft Office Suite.

Pay: $54.00 - $57.00 per hour

Benefits:

401(k)
Dental insurance
Health insurance
Vision insurance

Work Location: Hybrid remote in Austin, TX 78744

Quick Apply

Refine Your Search

medical device quality engineer jobs in austin, tx

Quality Systems Engineer (Medical Device)

Staff Quality Engineer

Quality Engineer

Product Quality & Reliability Engineer

Quality Engineer II

Senior Wire Harness Design Engineer (EWIS)

Manufacturing Engineer - Wire Harnessing

Senior Equipment Engineer

Welding Engineer - 182364

Quality Systems Engineer III

Senior Quality Engineer

Manufacturing Quality Engineer (MQE) - iPhone

Custom Timing and Verification CAD Engineer

Quality Systems Engineer

Quality Engineer

Sr Product Quality Engineer - Onsite

Quality Engineer, Optimus

Digital Design Engineer I

CPU Core Design Verification Engineer

Associate Controls Engineer

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