Top 3946 Senior Qa Jobs

Senior Quality Engineer
ECA Medical Instruments —Newbury Park, CA
- $110,000 - $135,000 a year
- Full-time
- Microsoft Outlook
- 5 years
- Computer literacy
- Health savings account
- Health insurance
Quick Apply
12d
Senior QA Analyst (Manual & Automated)
Yoh, A Day & Zimmermann Company —Plano, TX
- $38.50 - $55.00 an hour
- Contract
- Hybrid work
- 7 years
- SQL
- Bachelor's degree
- Health savings account
- Disability insurance
Quick Apply
Senior Computer System Validation Consultant - 29816_M
BEPC Inc —San Diego, CA
- $80.11 - $85.11 an hour
- Full-time
- Computer Science
- Bachelor of Science
- Engineering
- Health insurance
- Dental insurance
Quick Apply
Senior Quality Systems Engineer
Avanos Medical —Alpharetta, GA
- Full-time
- Management
- Engineering
- Master's degree
- Health insurance
- 401(k) matching
Senior Quality Program Specialist
Lonza —Walkersville, MD
- $95,000 - $153,000 a year
- Full-time
- 7 years
- Bachelor of Science
- Office
- Disability insurance
- Health insurance
Software QA (Senior Manager)
Intone Networks —Remote
- Contract
- Remote
- Management
- Senior level
Sr. QA Engineer
i2e Consulting —Remote
- Full-time
- Remote
- SQL
- Analysis skills
- APIs
Senior QA Engineer
AppMySite —Remote
- Full-time
- Remote
- Software troubleshooting
- Continuous improvement
- Senior level
Senior QA Analyst
Accelerate Learning Inc. —Remote
- Computer science
- Computer Science
- 5 years
Quick Apply
Sr. QA Analyst I
ABD Solutions —Chantilly, VA
- $122,000 a year
- Computer Science
- Senior level
Senior Associate, QA Compliance
Artiva Biotherapeutics —San Diego, CA
- $99,000 - $120,000 a year
- Full-time
- 5 years
- Bachelor's degree
- Senior level
- Paid holidays
- Disability insurance
Quick Apply
Senior Auditor, Food Safety
SGS —Remote
- $87,000 - $100,000 a year
- Full-time
- Basic math
- English
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
14d
Senior QA Engineer
Ziflow —Dallas, TX
- Remote
- 3 years
- Java
- Team management
Senior Lead Tester (508 Trusted Tester)
Astor & Sanders —McLean, VA
- $100,000 - $135,000 a year
- Full-time
- Hybrid work
- 6 years
- Computer Science
- Bachelor's degree
- Disability insurance
- Health insurance
Quick Apply
Senior Quality Assurance Analyst (Tester)
A P Ventures LLC —Remote
- Remote
- Microsoft Word
- Computer Science
- 5 years
Quick Apply
Senior QA Automation Engineer
PDF Solutions —Deer Park, IL
- $80,000 - $125,000 a year
- Full-time
- Remote
- Computer science
- 6 years
- Computer Science
Intermediate or Senior QA engineer
MoData —San Francisco, CA
- English
- Mid-level
- Windows
Senior QA Engineer
Synapse Health —Skokie, IL
- From $110,000 a year
- Remote
- Azure
- Data analysis skills
- Java
- Disability insurance
- Health insurance
Quick Apply
14d
Senior Quality Engineer (Remote - United States)
Solventum —Minnesota
- $106,000 - $145,750 a year
- Full-time
- Remote
- Laboratory experience
- High school diploma or GED
- Bachelor's degree
- Health savings account
- Disability insurance
Senior QA Associate I
AbbVie —North Chicago, IL
- $84,500 - $162,000 a year
- Full-time
- Hybrid work
- Mid-level
- Office
- 4 years
- Paid holidays
- Health insurance

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Senior Quality Engineer

ECA Medical Instruments -
Newbury Park, CA

Quick Apply

Job Details

Full-time
$110,000 - $135,000 a year
12 days ago

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Employee discount
Life insurance
Referral program

Qualifications

Customer communication
New product introduction engineering projects
Microsoft Outlook
Interpersonal skills
ISO standards
Quality control statistical data analysis
Writing skills
Statistical Process Control
Manufacturing facility experience
Statistical analysis
Bachelor's degree in engineering
Regulatory/legal compliance standards in production
Cleanroom experience
Biomedical regulatory compliance
Root cause analysis
FDA regulations

Full Job Description

Job Summary:

The Sr. Quality Engineer will primarily work on projects with Quality, Operations and Engineering groups, supporting new product launches and the manufacturing lines that produce our products. This role will include writing and reviewing design verification and validation protocols and reports, working on process validation (IQ, OQ, PQ), performing statistical analysis as required in verifications and validations as well as perform other quality management system tasks such as auditing, complaint investigations and implementing corrective actions as appropriate. This role will support Quality Engineering Manager with change order reviews, Design & Development File documentation creation and reviews.

Duties and Responsibilities:

Responsible for participation in new product development activities as the Quality engineering lead to ensure that all validations are accurately completed.
Lead and coordinate all quality engineering deliverables and activities to ensure completion in accordance with project timelines
Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
Prepare, review, execute, and summarize validation protocols (IQ, OQ, PQ) for a Class I medical device manufacturing facility with a main focus on molded parts.
Collaborate with project team on machining, molding, packaging and cleanroom activities related to new launch products
Review and approve documents through Change Order process.
Responsible for collaborating with Quality, product development and manufacturing to develop inspection plans for devices being developed
Responsible for Investigating and troubleshooting product complaints or production issues.
Responsible for ensuring that workflows, processes, and products comply with regulations
Collaborate with project team to develop inspecting and testing methods, equipment, processes, and criteria to ensure quality specifications are met.
Ensure validation efforts are conducted in an appropriate and timely manner; follow up with applicable departments independently.
Support risk assessment exercises related to validation and product development activities.
Identify deviations from established product or process standards and provide recommendations for resolving deviations.

Qualifications:

Requires a Bachelor's degree in Engineering
At least Five years’ work experience in a regulated industry (medical device preferred)
Demonstrated knowledge and understanding of FDA regulations, Quality System Regulations 21 CFR Part 820, ISO 13485, EU MDR, ISO 14971
Experience working with new product launch teams
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
Excellent computer proficiency (MS Office – Word, Excel and Outlook)
Strong analytical skills with the application of statistical methods (e.g., SPC, DOE, capability analysis, etc.)
Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
Experience with molding and machining process validation and molded parts is preferred
Experience with cleanroom and packaging activities is preferred

Work Environment: While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts and vibration. The employee is frequently exposed to a variety of varying weather conditions, trash, waste, chemicals and other materials. The noise level in the work environment and facility grounds can be loud.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. This position is very active and requires standing, walking, bending, kneeling, stooping, crouching, crawling and climbing all day. The employee must frequently lift or move items over 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Requires travel between buildings as well as to and from retail/wholesale suppliers. May require travel to remote locations.

Pay: $110,000.00 - $135,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Employee discount
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Referral program
Vision insurance

Application Question(s):
*
Do you have experience working with new product development and launches?

Do you have experience performing statistical analysis to make decisions?
Do you have experience with component and equipment validations using IQ/OQ/PQ?
Do you have experience leading projects and quality engineering initiatives?

Experience:

New product development: 1 year (Required)

Work Location: In person

Quick Apply

Refine Your Search

Senior Qa jobs

Senior Quality Engineer

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