Principal Quality Engineer – Development Quality

Thousand Oaks, CA, USA

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

Welcome to Amgen, where our mission is to serve patients by transforming the practice of medicine. We are currently seeking a highly motivated and experienced Principal Quality Engineer to join our Development Quality team. As a member of this team, you will play a crucial role in ensuring the quality of our development processes and products, ultimately impacting the lives of patients worldwide. This is an exciting opportunity for an individual with a passion for quality and a strong background in engineering to make a meaningful impact in the healthcare industry. If you are a driven and collaborative individual with a track record of success in quality engineering, we encourage you to apply for this role.

Develop and implement quality assurance strategies and protocols to ensure the highest level of quality in development processes and products.
Collaborate with cross-functional teams to establish and maintain quality standards and procedures.
Conduct risk assessments and identify areas for improvement in development processes.
Lead and participate in quality audits and inspections to ensure compliance with regulatory standards.
Analyze data and trends to identify opportunities for improvement and make recommendations for corrective actions.
Provide guidance and support to engineering and development teams in implementing quality standards and processes.
Stay updated on industry best practices and trends in quality engineering and incorporate them into the development process.
Serve as a subject matter expert on quality engineering principles and processes.
Communicate effectively with internal and external stakeholders to ensure alignment and understanding of quality standards and procedures.
Mentor and train junior quality engineers on best practices and procedures.
Participate in the development and maintenance of quality metrics and dashboards to track and report on quality performance.
Proactively identify and address potential quality issues and risks.
Foster a culture of quality and continuous improvement within the organization.
Manage and prioritize multiple projects and tasks effectively to meet deadlines.
Uphold Amgen's mission and values in all interactions and work to positively impact the lives of patients worldwide.

Where is this job?

This job is located at Thousand Oaks, CA, USA

Job Qualifications

Extensive Experience In Quality Assurance: A Principal Quality Engineer – Development Quality At Amgen Should Have At Least 10 Years Of Experience In Quality Assurance, With A Focus On Pharmaceutical Or Biotechnology Industries. This Experience Should Include A Strong Understanding Of Quality Management Systems, Regulatory Requirements, And Industry Best Practices.
In-Depth Knowledge Of Development Processes: The Ideal Candidate Should Have A Deep Understanding Of The Drug Development Process, Including Preclinical, Clinical, And Commercial Stages. This Knowledge Should Include A Strong Understanding Of Regulatory Requirements And Guidelines, As Well As Experience With Risk Management And Quality Control.
Strong Leadership Skills: As A Principal Quality Engineer, This Role Requires Strong Leadership Skills To Effectively Manage A Team And Work Cross-Functionally With Other Departments. The Candidate Should Have A Proven Track Record Of Leading A Team, Setting And Achieving Goals, And Driving Continuous Improvement.
Excellent Communication And Collaboration Skills: Collaboration And Communication Are Critical For Success In This Role. The Candidate Should Have Excellent Written And Verbal Communication Skills To Effectively Communicate With Stakeholders At All Levels Of The Organization. In Addition, They Should Have The Ability To Collaborate With Cross-Functional Teams To Drive Quality Initiatives.
Advanced Degree In A Relevant Field: A Principal Quality Engineer At Amgen Should Have An Advanced Degree In A Relevant Field Such As Engineering, Chemistry, Or Pharmaceutical Sciences. This Education Provides A Strong Foundation For Understanding Complex Quality Issues And The Ability To Effectively Problem-Solve And Make Data-Driven Decisions.

Required Skills

Process Improvement
Validation
Data Analysis
Quality Management
Auditing
Root Cause Analysis
Change control
Team Leadership
Risk assessment
Regulatory compliance
Supplier management
Training And

Soft Skills

Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
collaboration
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Principal Quality Engineer – Development Quality in Thousand Oaks, CA, USA is $130,000-$175,000 per year. However, this may vary depending on the specific company, years of experience, and individual skills and qualifications.

Additional Information

Amgen is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedAugust 13th, 2024

Apply BeforeSeptember 18th, 2025

This job posting is from a verified source.

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