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Added 4 mins ago
Sr Project Manager - AI Data Centers
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Serve as the primary coordination point among the client, Project Engineer, discipline design teams, construction management, commissioning teams, vendors, and subcontractors.
Added 17 mins ago
Ground Software DevOps Release Engineer III (TS/SCI Required) - Blue Ring
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…space missions and advancing ground capabilities. The DevSecOps Engineer will bridge the gap between development, security, and operations. In this role, you will own the end-to-end…
Added 45 mins ago
Field Service Engineer - 304344
Delaware Nation Industries
Fort Stewart, GA
DNI Emerging Technologies is seeking a qualified Field Service Engineer to support the Army Systems Engineering and Program Management Services (Army SEPM) at Fort Stewart, GA.
Added 45 mins ago
DN
Cybersecurity System Engineer-306341
Delaware Nation Industries
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- $140,000 to $145,000 USD / year
Systems Integration Engineer IV is responsible for the design, development, and implementation of security and monitoring technology solutions in support of a federal agency's…
Added 2 hours ago
Weld Engineer/Welding Engineering Technologist
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Taylor Defense Products is seeking a highly motivated Weld Engineer or Welding Engineering Technologist to support the development, qualification, production, and continuous improvement of…
Added 2 hours ago
Electrical Hardware Engineer Intern
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Controls Engineer (HE) (56293)
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Added 3 hours ago
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Member of Technical Staff, Forward Deployed Engineer
Odyssey
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- $164,800 to $508,000 USD / year
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Added 3 hours ago
Production Engineer
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Senior PCB Layout Engineer
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Design Standards: Comprehensive knowledge of manufacturing and drafting standards, including GD&T and IPC classifications (IPC-2221, IPC-6012, IPC-6013).
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Robotics Software Engineer
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- $130,000 to $180,000 USD / year
…robotics stack, turning software into reliable performance in physical…
Added 4 hours ago
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Process Engineer
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Senior Cloud Security Engineer
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Working in a high-velocity sales environment, the Presales Engineer supports multiple opportunities simultaneously and partners closely with sales teams to drive customer success and…
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Added 5 hours ago
C-
Principal Software Engineer - Full Stack
CVector - Industrial AI
Remote, United States
- $150,000 to $175,000 USD / year
As a Principal Full Stack Software Engineer, you will own the technical direction of CVector’s customer-facing platform end to end - from the real-time data visualization and AI-driven…
Added 5 hours ago
C-
Principal Software Engineer - Backend & AI Infra
CVector - Industrial AI
Remote, United States
- $150,000 to $175,000 USD / year
As a Principal Software Engineer - Backend & AI Infra focus, you will play a critical role in evolving CVector’s core backend platform. You will work on time-series data systems,…

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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