quality engineer Minnetonka, MN
Halozyme
Full Time
Minnetonka, MN
148000 - 108000 USD ANNUAL Today
Job description
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Manager, Quality Engineering- This position is located in our Minnetonka, MN site.
Welcome to an inspired career.
At Halozyme, we’re proud of what we do, and we continue to do more. That’s why we need you—to help us make a significant impact by tackling increasingly complex challenges, leaping beyond the status quo and advancing our mission.
Join us as Manager, Quality Engineering 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 Manager, Quality Engineering leads a team of design assurance and quality engineers in addition to directly performing quality engineering (individual contributor) work as assigned. In this role, they use Quality Engineering tools, methods, and principles for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. They ensure effective risk management to prevent unanticipated failure modes and improve capability of processes.
In this role, you’ll have the opportunity to:
- Provide supervision, mentoring, coaching, performance review, developmental plans, and succession planning for Quality/Design Assurance Engineers
- Handle escalation of quality issues as appropriate
- Partner with R&D and other cross-functional partners to ensure the accurate application of design controls, risk management, DHF/DMR compilation, and the investigation/correction of design failures.
- Owns and is accountable for risk assessment process including conducting, documenting, reviewing, and maintaining current risk and hazard analysis documentation such as FMEAs
- Supports product requirement and engineering print specification definitions, development, and changes
- Develops and maintains product release testing plans, associated test methods and procedures
- Supports internal and external audits
To succeed in this role, you’ll need
- Bachelor’s degree in engineering (Mechanical, Material Science or Biomedical) or related Physical/Biological Science with minimum of 5 years of experience in a quality engineering function in the medical device or combination product (drug, device, and/or biologics) industries (a combination of education and experience may be considered)
- A minimum of 2 years of experience in a management/supervisory role with strong mentoring, coaching, and leadership skills
- Strong communication skills (verbal and written), including interfacing with internal customers, third party partners (customers), and regulatory agencies
- Strong statistical data analysis skills and experience with design, process, and test method validations
- Experience working in both an FDA and EU regulatory environment is preferred.
In return, we offer you:
- Hybrid work flexibility
- 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.
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.
The most likely annual salary for this position is between $108K - $148K annually. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual’s exact level of compensation.
About Halozyme
CEO: Helen Torley
Revenue: $100 to $500 million (USD)
Size: 201 to 500 Employees
Type: Company - Public
Website: www.halozyme.com
Year Founded: 2001
Halozyme
www.halozyme.com
San Diego, CA
Helen Torley
$100 to $500 million (USD)
201 to 500 Employees
Company - Public
Biotech & Pharmaceuticals
2001
