Quality Engineer 3

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 [email protected] 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