Engineer 2, Quality

Join us as an Engineer 2, Quality, and you'll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people's 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, you'll 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 required), and manufacturing process development & qualification for product changes

• Support DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

• 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

• 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 impact-on 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 individual's 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 hrbox@halozyme.com.

To view all our open positions, please visit our career page. Additionally, our benefit offerings can be found here.