What are the responsibilities and job description for the Sr Quality Engineer Specialist position at Grifols?
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Summary:
The Sr. QA Specialist will interact with personnel from various departments within Grifols as the QA project core team representative, ensuring compliance with company policies and other standards. Participate in the development of new products!
Additionally, this role will be integral in creating a process for performing system validations when reagents, software, and/or hardware are modified in previously validated products.
Primary responsibilities for role:
?Independently performs moderately complex tasks (such as writing procedures/reports and performing validations) in support of NPD and system validation.
?Ensures governing documents for NPD and system validations are in accordance with HA regulations (such as ISO 13485 and 21 CFR 820) and company policies/standards.
?Cross-functional coordination with other departments as it relates to NPD and system validation.
?Interacts with regulatory and partner auditors/inspectors.
?Represents QA interests on special projects related to NPD and system validation.
Education:
Requires degree(s) in molecular biology, biology, chemistry, biomedical engineering, computer science or a related field. • Quality certification (from American Society for Quality or equivalent), is a plus.
Experience:
Previous experience with new product development and/or assay development a must.
Experience following and implementing design controls is a must.
New product development of software and/or hardware is a plus.
Experience with leading and/or performing investigations is a plus.
Equivalency:
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. For this role, a Bachelor's degree 6 years experience, a Master's degree 4 years experience, or a PhD 2 years experience are acceptable.
Pay Scale:
Pay scale of $102,871 - $154,306 Salary, depending on training, education, and experience. This position is eligible to participate in up to 8% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!
Occupational Demands:
May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.
EEO Minorities/ Disability/Veterans
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg
Recommended Skills
- Perform Statistical Analysis
- Product Quality Assurance
- Quality Assurance
- Quality Management Systems
- Corrective And Preventive Action (Capa)
- Statistical Process Controls
Salary : $102,871 - $154,306
