Engineer 2, Quality
Engineer 2, Quality
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site.
In order to move forward you will need to create an account. Your password must be eight characters long contain at least one special character one capital letter and a number.
We look forward to discovering your talents.
Welcome to an inspired career.
At Halozyme we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together as One Team we rise by lifting others up and believe in the power of working together for the collective win. Thats why we need youto help us make a significant impact by taking on increasingly complex challenges leaping beyond the status quo advancing our mission and making our One Team culture thrive.
Join us as an Engineer 2 Quality and youll be part of a culture that welcomes diversity thinks differently to solve problems works collaboratively as one team and delivers meaningful innovations that impact peoples lives.
How you will make an impact
The Engineer 2 Quality leads quality engineering activities for commercial products including process validation maintenance of DMR and risk management files complaint risk analysis and CAPA/SCAR/Deviation investigations. This position also participates in quality engineering activities for commercial scale up prior to product launch. Through these activities the Quality Engineer 2 will verify quality reliability and compliance of mechanical product designs.
In this role youll have the opportunity to:
Evaluate mechanical product design and identifies potential design quality issues and drives technical decisions
Drive design quality reliability and compliance to standards and regulations
Assist on-time completion of Design Control Deliverables
Maintain risk management files for commercial products via periodic review of risk documents complaints and nonconformance trends
Maintain release testing plans and associated test methods and procedures
Lead CAPA/NCR/SCAR investigations and reports
Review supplier documentation in accordance with established requirements
Support internal & external audits complaint investigations quality system development (as ) and manufacturing process development & qualification for product changes
Support DMR content completion integrity and regulatory & standards compliance; collaboratively communicating & resolving gaps
To succeed in this role youll need:
Bachelor level degree in Engineering (Mechanical Material Science or Biomedical) or related Science with minimum of 3 years relevant experience within the medical device industry or related function (An equivalent combination of experience and education may be considered)Knowledge of GMP ISO QSR and other applicable international regulations standards Directives and Guidance
Experience with participation in audits
Validation Experience highly preferred
Lead auditor certification preferred
Design for Six Sigma and Critical to Quality training and experience a plus
ASQ certification a plus
Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus
In return we offer you:
Full and comprehensive benefit program including an Employee Stock Purchase Program and 401(k) matching.
Opportunities to grow in a culture that prioritizes learning development and progression through in-house programs and tuition reimbursement.
A collaborative innovative team that works as one to amplify your impacton your career the work you do and patients lives.
The most likely base pay range for this position is $71K - $100K per year. Several factors such as experience tenure skills and particular business needs will determine an individuals exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses sales incentives and equity awards.
Halozyme Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race color religion sex sexual orientation gender identity national origin age protected veteran or disabled status or genetic information.
Accessibility and Reasonable Accommodations:
Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability contact Human Resources at .
To view all our open positions please visit our career page. Additionally our benefit offerings can be found here.
Employment Type
Full-Time
