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Sr. Advanced Systems Engineer - Displays and Touch Screen Controllers
Real Time Consulting, LLC
Phoenix, AZ
JOB TITLE: Sr. Advanced Systems Engineer - Displays and Touch Screen Controllers
Added just now
Systems Engineer - Aircraft Surveillance Systems
Real Time Consulting, LLC
Phoenix, AZ
JOB TITLE: System Engineer - Aircraft Surveillance Systems
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Systems Engineer - Automatic Flight Controls
Real Time Consulting, LLC
Phoenix, AZ
JOB TITLE: Systems Engineer - Automatic Flight Control Systems
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Systems Engineer - Avionics Display Applications
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Phoenix, AZ
JOB TITLE: Systems Engineer - Avionics Display Applications
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Staff Product Designer, AI Control Tower
ServiceNow
San Diego, CA
It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could…
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Sr. Director, AMS Head of CEG Operations
ServiceNow
Santa Clara, CA
It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could…
Added 1 min ago
Validation Engineer - Menominee Area
The Pivot Group Network
Menominee · Menominee, MI
Are you a detail-oriented professional with a passion for excelling as a validation engineer? The Pivot Group Network, a Michigan manufacturing-focused recruiting group, is dedicated to…
Added 1 min ago
Field Service Technician - Mount Clemens Area
The Pivot Group Network
Mount Clemens · Mount Clemens, MI
Troubleshoot mechanical, electrical, and control system faults on site.
Added 1 min ago
Process Engineer - Adrian Area
The Pivot Group Network
Adrian · Adrian, MI
This posting covers Process Engineer opportunities with manufacturers based in and around Adrian in Lenawee County, within about 45 minutes of the city, including Tecumseh, Hudson, Morenci,…
Added 1 min ago
Quality Engineer - Iron Mountain Area
The Pivot Group Network
Iron Mountain · Iron Mountain, MI
This posting covers Quality Engineer opportunities with manufacturers based in and around Iron Mountain in Dickinson County, within about 45 minutes of the city, including Kingsford,…
Added 1 min ago
Continuous Improvement Leader - Monroe Area
The Pivot Group Network
Monroe · Monroe, MI
Familiarity with statistical process control and Minitab.
Added 1 min ago
Advanced Quality Engineer - Detroit Area
The Pivot Group Network
Detroit · Detroit, MI
Are you a forward-thinking professional with a passion for excelling as a advanced quality engineer? The Pivot Group Network, a Michigan manufacturing-focused recruiting group, is committed…
Added 1 min ago
Quality Supervisor - Warren Area
The Pivot Group Network
Warren · Warren, MI
Quality Assurance Supervisor, Quality Control Supervisor, Quality Manager, Quality Engineer, Quality Assurance Manager, Inspection Supervisor, Quality Team Lead, Supplier Quality Engineer,…
Added 1 min ago
Continuous Improvement Leader - Grayling Area
The Pivot Group Network
Grayling · Grayling, MI
Familiarity with statistical process control and Minitab.
Added 1 min ago
Continuous Improvement Leader - Mount Clemens Area
The Pivot Group Network
Mount Clemens · Mount Clemens, MI
Familiarity with statistical process control and Minitab.
Added 1 min ago
Field Service Technician - Escanaba Area
The Pivot Group Network
Escanaba · Escanaba, MI
Troubleshoot mechanical, electrical, and control system faults on site.
Added 1 min ago
Embedded Systems Engineer - Dearborn Area
The Pivot Group Network
Dearborn · Dearborn, MI
Are you a skilled professional with a passion for excelling as a embedded systems engineer? The Pivot Group Network, a Michigan manufacturing-focused recruiting group, is dedicated to…
Added 1 min ago
Automation Engineer - Gladwin Area
The Pivot Group Network
Gladwin · Gladwin, MI
This posting covers Automation Engineer opportunities with manufacturers based in and around Gladwin in Gladwin County, within about 45 minutes of the city, including West Branch, Standish,…
Added 1 min ago
Field Service Technician - Croswell Area
The Pivot Group Network
Croswell · Croswell, MI
Troubleshoot mechanical, electrical, and control system faults on site.
Added 3 mins ago
Mechanical Engineer
Salient Motion
Hawthorne, CA · 4857 W 147TH St Hawthorne, CA
…about disrupting legacy industries, and passionate about motor control technology, let's…
Added 4 mins ago
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Data Engineer 2
Choice Hotels
North Bethesda, MD
- $107,000 to $127,000 USD / year
Choice Hotels, one of the world’s largest lodging franchisors, has an exciting new opportunity as our Data Engineer II in the Data Engineering team within our Advanced Analytics Team. The…
Added 4 mins ago
S
Building Automation Controls Engineer
Siemens
Beltsville, MD
- $70,894 to $121,533 USD / year
…compliant, and commissioning‑ready engineering packages. The Engineer ensures alignment between contract scope, design intent, and execution strategy while supporting complex projects…
Added 4 mins ago
Senior Automated Test Engineer
Leidos
Gaithersburg, MD
Leidos is seeking a Senior Test Automation Engineer to help deliver mission-essential software capabilities that enable intelligence professionals to access critical information, analyze…
Added 4 mins ago
Data Operations Engineer (Hybrid) - 30862
Huntington Ingalls Industries
Fort Meade, MD
Added 4 mins ago
Global Partner Manager – Autonomous Workforce/GBS, Deloitte
ServiceNow, Inc.
Silver Spring, MD
It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could…

Werfen

Quality Engineer III

San Diego, CA, United States

$100,000 to $125,000 USD / year

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Job details

Pay: $100,000 to $125,000 USD / year
Apply by: Nov 3, 2027
Posting language: English
Posted: Nov 3, 2024

Original job description

Introduction

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Position Summary:

The Quality Engineer III creates various quality system documents including procedures and work instructions. Quality Engineer III will support a wide range of quality-related engineering activities including, but not limited to, process development, product development, risk management, root cause investigation, risk assessments and verification/validation. The Quality Engineer III, Quality will support and/or lead continuous improvement projects and will be a key resource for the organization in the proper use of statistics including capability studies, gage R&R, test method validation and acceptance sampling plans.

The annual base salary range for this role is currently $100,000 to $125,000. This is a bonus-eligible position. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.

Responsibilities

Key Accountabilities:

Write, review, and approve quality system documents which comply with applicable regulations and standards.
Participate and/or lead process validation teams.
Work cross-functionally, as a key resource, to solve problems related to product or process quality issues; investigate non-conformances, identify root cause, and determine/implement appropriate corrective action plans.
Support design control project teams: ensure predetermined requirements are met and that compliance is maintained.
Participate in internal and external audits.
Conduct risk and trend evaluations for product non-conformances.
May prepare technical microbiology and sterility assurance reports and formulate microbiology or sterility assurance recommendations for disposition or other actions related to product non-conformances.
Works with manufacturing, R&D, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA).
Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required.
Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies. Supports internal and external audits.
Ability to prioritize urgent matters.

Networking/Key relationships:

Manufacturing/Operations
Manufacturing Engineering
Regulatory Affairs
Research & Development
Service

Qualifications

Minimum Knowledge & Experience Required for the Position:

Bachelor’s degree, or equivalent, plus a minimum of (3) to five to (5) year previous experience, preferably within a regulated medical device or pharmaceutical environment
Knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, EN ISO 14971:2012,) to the R&D environment
ASQ certification and/or Six Sigma Green/Black belt preferred
Broad knowledge of quality engineering principles required
Broad knowledge of Quality System Regulations required
Previous experience with statistical sampling and analysis, design of experiments (DOE) and validation required
Good technical writing skills required
Good communication and presentation skills
Knowledge of Microsoft Office required; knowledge of statistical software, and experience with large enterprise resource planning (ERP) system required
Demonstrated good problem solving skills required
Strong planning and organizational skills required
Expertise in Gamma Sterilization a plus
Ability to lead cross functional projects to timely and effective conclusion
Ability to collaborate internally and externally; working with vendors and subcontractors; and consultants with no supervision
Understands and demonstrates aseptic technique.
Experience with GLP principles.

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com

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