20 Best Senior Quality Engineer jobs (Hiring Now!)

Senior Quality Engineer
Seek Labs —Salt Lake City, UT
Provide quality guidance on product design and development efforts, including design control aspects such as design inputs, design verification, design outputs,…
Estimated: $89.1K - $113K a year
Quick Apply
Senior (Physical) Substation Engineer
ECF Engineering Consultants —West Palm Beach, FL
Perform a senior role in the substation design, preparation of specifications, administration functions, or field engineering related to assigned engineering…
$116,315 - $136,739 a year
Quick Apply
Senior NPPD Engineer
TEEL PLASTICS INC —Baraboo, WI
Supports manufacturing when technical consultation is required to solve more complex technical issues that arise. Domestic and international travel required.
$92,000 - $138,000 a year
Quick Apply
Senior Design Engineer
Karpatia Trucks —Middlebury, IN
The ideal candidate will have extensive experience in 3D rendering, permit set preparation, and fabrication design, as well as strong project management skills…
$25 - $35 an hour
Quick Apply
Sr. Manufacturing Engineer
Ascential Medical & Life Sciences —Andover, MN
Responsible for supporting the Production Services Operations Team with engineering programs, procedures, and systems that deliver products that consistently…
$90,000 - $100,000 a year
Quick Apply
Senior Electrical Engineer
MDP Engineering Group —Denver, CO
Conduct field surveys, engineering calculations, and assessments of existing electrical systems. Design and implement complex electrical systems for commercial…
$125,000 - $180,000 a year
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12d
Senior Transmission Line Engineer
ECF Engineering Consultants —West Palm Beach, FL
Perform a lead role in the detailed design of 69-500kv transmission line projects, preparation of specifications administrative functions or field engineering…
$116,315 - $136,739 a year
Quick Apply
Senior Quality Engineer
CentralReach —Holmdel, NJ
Experience with scripting/programming languages to develop test automation scenarios for web and/or mobile applications, and API services.
$120,000 a year
Quick Apply
3d
Senior Control Systems Engineer
Midwest Automation Inc. —Maryland Heights, MO
Provide technical support in the design & manufacturing of each project. Lead engineering responsibilities for a portfolio of projects in varying business…
Estimated: $104K - $132K a year
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Senior Plumbing Design Engineer
MTech Mechanical —Westminster, CO
Involvement in all facets of a project, from conceptual design, design engineering, LEED analysis and documentation, construction observation, trouble-shooting,…
$90,000 - $125,000 a year
Quick Apply
5d
Senior Quality Engineer
Imperium Life Sciences —Monroe, NC
Bachelor’s degree in engineering or a related field; Master’s degree preferred. Able to read and understand technical drawings and documents.
$110,000 - $135,000 a year
Quick Apply
3d
Senior CMT Engineer
Legacy Engineering —Jacksonville, FL
Valid state driver's license and acceptable motor vehicle record. Perform field testing when required to provide engineering recommendations on projects through…
$90,000 - $150,000 a year
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Manufacturing Engineer - Sr
McNeilus Truck & Mfg Inc —Dodge Center, MN
Assists in design for manufacturability for new product development through participation on cross functional product design teams.
Estimated: $93.9K - $119K a year
Senior Avionics Engineer
YINGLING AVIATION —Wichita, KS
The Avionics Engineer, Sr. is responsible for the design, development, testing, and implementation of avionics and electrical engineering projects.
Estimated: $86.5K - $109K a year
8d
Senior Logistics Engineer
Country Intelligence Group, LTD —Lexington Park, MD
Will direct and coordinate program activities designed to provide sub-contractors, management, and customers with logistics technology that ensures effective…
Estimated: $112K - $141K a year
Quick Apply
Senior Quality Assurance Engineer
Zartico, Inc. —Remote
Collaborative Approach: Work closely with cross-functional teams, including engineering, data science, product managers, and business analysts, to facilitate…
Estimated: $93.2K - $118K a year
Quick Apply
Senior Electrical Engineer
FloodGate Medical —Minneapolis, MN
You'll oversee the disposition of nonconforming materials and devices, and tackle field issues, CAPAs, complaints, and clinical adverse events.
$120,000 - $140,000 a year
Quick Apply
12d
Senior Quality Assurance Engineer
EarnIn —Remote
As a full stack QA engineer you will help us design and develop test automation to ensure product quality and improve users' experience.
$136,500 - $203,500 a year
Quick Apply
Senior Quality Engineer-Risk and Post Market- GR, MI or remote
AirLife —Grand Rapids, MI
Collaboration with cross-functional teams to develop and implement risk mitigation plans. Conduct risk assessments, including the identification of hazards,…
Quick Apply
9d
Senior Protection & Control Substation Engineer
ECF Engineering Consultants —West Palm Beach, FL
Perform a lead role in the substation design, preparation of specifications, or field engineering related to assigned engineering projects under the supervision…
$116,315 - $136,739 a year
Quick Apply

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Senior Quality Engineer

Seek Labs - Salt Lake City, UT

Quick Apply

Job Details

Full-time Estimated: $89.1K - $113K a year

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Parental leave

Qualifications

Six Sigma Black Belt
Six Sigma Certification
ISO 9001
Bachelor's degree
Certified Quality Auditor
Product management
Communication skills
Certified Quality Engineer
FDA regulations
Training delivery
Product lifecycle management

Full Job Description

JOB DESCRIPTION SUMMARY

The Senior Quality Engineer will assist in managing the global quality systems and regulatory compliance strategy for invitro diagnostics (IVD), focusing on at-home and point-of-care molecular diagnostic platforms. The primary responsibilities include developing and continuously improving QMS processes to support product development, manufacturing, and business objectives, ensuring compliance with relevant government regulations and standards. This position reports to the Director of Quality and Regulatory Affairs. Please note that only qualified individuals being considered will be contacted.

ESSENTIAL FUNCTIONS

Support development and maintenance of an effective QMS, ensuring compliance with government regulations (FDA’s QSR and other relevant country-specific regulations) and applicable standards (ISO 13485, ISO 14971, MDSAP, etc.) for IVD products
Assist in authoring, reviewing, and revising QMS documents including quality manual, procedures, work instructions, etc.
Collaborate with management to facilitate the implementation and ongoing effectiveness of the QMS through the use of quality policy, business and quality objectives, and quality plan activities
Provide quality guidance on product design and development efforts, including design control aspects such as design inputs, design verification, design outputs, design validation, usability/human factors, process validation, test protocols, reports, and design transfer
Assist in authoring, reviewing, and/or approving DHF documentation. Ensure that all relevant development phase requirements are adequately fulfilled and documented within the DHF before allowing the project to proceed further in the development process.
Assist in the creation and maintenance of risk management documents for products under design control or for released products, including risk management plans, reports, risk analysis documents, risk management files, and FMEAs
Assist in overseeing manufacturing and validation activities to ensure they are well-established and compliant with all relevant agency and internal quality requirements
Collaborate with Operations and CMO during design transfer to ensure comprehensive and efficient completion of product DMR and effective knowledge transfer
Support the management of non-conformances, CAPA, failure investigation, product disposition, deviations, customer feedback, complaint handling, field actions, product recalls, reporting, post market surveillance, and additional quality assurance tasks
Lead and administer the Engineering Change Orders (NCOs) workflow, document control activities, and other electronic process workflows in the eQMS. Review for quality and regulatory impact in accordance with requirements from regulatory agencies and internal stakeholders.
Coordinates internal/external audits and government agency inspections
Aid in establishing supplier quality requirements, review supplier purchase orders to verify compliance with those requirements, and conduct supplier qualification, audits, and ongoing monitoring
Support in defining and monitoring key quality performance metrics to ensure continuous improvement in product quality, while also establishing product quality and process metrics that effectively measure and improve performance
Maintain strong connections with engineering, R&D, regulatory affairs, manufacturing, business development, and other functions to effectively fulfill quality-related responsibilities
Provide guidance and training to internal eQMS users, ensuring that all employees receive tailored instruction on QMS policies and procedures pertinent to their respective roles
Stay current with emerging scientific methods, evolving standards, regulations, and industry trends influencing the organization. Propose adjustments or enhancements to processes, systems, or designs in response to these developments.
Performs other duties and responsibilities as assigned

QUALIFICATIONS

(Required)

Bachelor's degree, preferably in engineering or science, or related field plus a minimum of six (6) years of practical experience as a Quality Engineer supporting a commercially available Class II/III active medical device (preferably IVD), or an equivalent combination of education and experience
Strong working knowledge of quality system regulations and standards, including FDA’s QSR (21 CFR Part 820), ISO 13485, ISO 9001, ISO 14971, cGMP, CLIA, and QSIT
Proficient in utilizing quality tools/methodologies including Investigation and Root Cause Analysis, CAPA, Risk Analysis, Statistical Analysis, dFMEA, pFMEA, pareto chart, Ishikawa, flowchart, 5 whys, histogram, 8D, etc.
Experience in medical device design & development, V&V activities, risk management, product transfer, DHF processes
Proficient in utilizing product life cycle management systems such as PLM/electronic QMS (e.g., Arena, MasterControl)
Skilled in drafting procedures, work instructions, reports, and business correspondence with meticulous attention to detail and exceptional accuracy in documentation
Strong written and verbal communication skills, with proficiency in articulating information clearly and effectively addressing inquiries from management, peers, suppliers, government agencies, and customers
Capable of problem identification, data gathering, fact establishment, and drawing valid conclusions. Proficient in interpreting a wide range of technical instructions presented in mathematical or diagrammatical forms, and adept at handling various abstract and concrete variables.
Experience with conducting audits
Experience with delivering training material to groups
Highly independent and self-motivated and integrates well in multi-disciplinary teams
Versatility in navigating a dynamic, fast-paced, small company setting

(Preferred)

ASQ Certification (e.g., CQE or CQA) or equivalent (e.g., Certified Six Sigma Black Belt)

Essential Physical/Environmental Demands:

Extended periods of sitting and computer use.
Ability to operate standard office equipment, such as computers, printers, and phones.
Occasional lifting of light office supplies and materials.
Working in a climate-controlled office environment.
Following ergonomic best practices to prevent strain or injury.
Visual acuity, color perception, and depth perception for tasks such as reading documents and navigating computer screens.

Our EEO Policy

Seek Labs is dedicated to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, national origin, age, disability, genetic information, sexual orientation, gender identity, or any other characteristic protected by law. We prohibit discrimination, harassment, and retaliation in all aspects of employment, and we strive to foster a diverse and inclusive workplace where everyone is treated with respect.

*Must be authorized to work in the United States. No immigration-related sponsorships are available.

Schedule: 9/80 work schedule with every other Friday off

Job Type: Full-time

Benefits:

401(k)
Dental insurance
Flexible spending account
Health insurance
Health savings account
Paid time off
Parental leave

Ability to Relocate:

Salt Lake City, UT 84103: Relocate before starting work (Required)

Work Location: In person

Quick Apply

Senior Quality Engineer jobs

Senior Quality Engineer

Senior (Physical) Substation Engineer

Senior NPPD Engineer

Senior Design Engineer

Sr. Manufacturing Engineer

Senior Electrical Engineer

Senior Transmission Line Engineer

Senior Quality Engineer

Senior Control Systems Engineer

Senior Plumbing Design Engineer

Senior Quality Engineer

Senior CMT Engineer

Manufacturing Engineer - Sr

Senior Avionics Engineer

Senior Logistics Engineer

Senior Quality Assurance Engineer

Senior Electrical Engineer

Senior Quality Assurance Engineer

Senior Quality Engineer-Risk and Post Market- GR, MI or remote

Senior Protection & Control Substation Engineer

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