Staff Quality Engineer - Biocompatibility & Sterilization

Imperative Care; Campbell (CA); On-site; USD 151,000 - 161,000; Full time

Job summary

Imperative Care is seeking a Staff Quality Engineer in Campbell, California to lead processes ensuring compliance with quality standards in the development of medical device products. The role involves deep expertise in sterilization, microbiology, and biocompatibility, along with the opportunity to impact patient care directly through innovative technologies. Candidates should have a BS in Engineering and extensive experience in a regulated industry, with excellent communication skills.

Benefits

Stock options

Competitive salaries

401k plan

Health benefits

Generous PTO

Parental leave program

Qualifications

• 8+ years of relevant experience or equivalent combination of education and work experience.
• Strong knowledge of ISO standards related to Sterilization and Microbiology.
• Excellent communication skills and ability to review technical documentation.

Responsibilities

• Establish and support processes for compliance with quality standards.
• Lead sterilization and microbiology activities for product development.
• Collaborate cross-functionally on product improvement projects.

Skills

Sterilization

Microbiology

Biocompatibility

Quality Systems

Data Analytics

Education

BS in Engineering or similar discipline

Job description

Title:Staff Quality Engineer – Biocompatibility & Sterilization
This position is based in our Campbell, California offices. This position is on-site, full-time.

Why Imperative Care?
Do you want to make a real impact on patients?
As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do.

What You’ll Do
The Staff Quality Engineer is the subject matter expert who establishes and or supports processes, protocols, methods, and techniques to ensure compliance with quality standards and regulatory requirements during the development, manufacture and distribution of our medical device products. This role will involve leading sterilization and microbiology activities and/or overseeing the work of more junior team members or contracted testing laboratories, depending on focus area.

• Hands on experience with deep knowledge in terminal sterilization modality (Ethylene Oxide preferred) and understands applicable ISO and guidance documents related to sterility assurance-Sterilization (ISO11135) , Microbiology (ISO 11737 series and ISO 11138 series), Cleanrooms (ISO 14644 series, ISO 14698, AAMI TIR 52) and Quality Systems (ISO 13485). And understanding of Biocompatibility (ISO 10993 series).
• Develop and execute quality plans and provide strategic input throughout the product development lifecycle to ensure products comply with regulatory and internal quality systems requirements. Share data analytics related to quality metrics with focus on Microbiology, Sterilization and Biocompatibility.

• Provides microbiological, sterilization and biocompatibility technical expertise during new product development activities, process modification studies and failure investigations regarding microbiological contamination control, impact to product and validated sterilization cycles. Serves as technical liaison with functional groups, contract laboratories and manufacturing sites.
• Support Risk Management Report process and contribute to the development of Use Risk, Design Risk and Process Risk documentation as it relates to Microbiology, Sterilization and Biocompatibility.
• Collaborate cross-functionally on pilot production of new products and improvement projects.
• Establish and maintain quality assurance procedures and educate peers on their use for Microbiology, Sterilization and Biocompatibility.
• Support management of relationships with suppliers and testing laboratories by supporting development of quality agreements, assessing performance, troubleshooting failures and creating corrective action plans.
• Participate in supplier qualification activities, including on-site audits and evaluations as it relates to Microbiology, Sterilization and Biocompatibility.
• When a position’s focus is microbiology, sterilization and biocompatibility, lead all activities and projects related to laboratory selection, compliance audits, along with testing analyses and results interpretation.
• Develop and implement sterilization protocols and procedures according to regulations.
• Plan and execute validation studies of sterilization and assessments and requalification activities.
• Generate Biological Evaluation Plans (BEPs), analyze testing results and assess biocompatibility risks. Advise on biocompatibility tests to be performed.

What You’ll Bring:

• BS in Engineering or similar discipline and 8+ years of relevant experience; or equivalent combination of education and work experience
• Master’s degree and catheter, endovascular, or neurological device experience or related regulated industry is preferred.
• Acumen in identifying risks through CAPAs, NCMR/NCRs, SCARs, etc., and supporting improvements with suppliers, stakeholders and other vendors.
• Strong knowledge of Sterilization (ISO11135) , Microbiology (ISO 11737 series and ISO 11138 series), Cleanrooms (ISO 14644 series, ISO 14698, AAMI TIR 52), Biocompatibility (ISO 10993 series), quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards (ISO 14971) and good manufacturing practices.
• Excellent communications skills (both written and verbal), with strong ability to review technical documentation and write meticulous, clear and concise procedures.
• Strong ability to perform multiple tasks concurrently and accurately.

Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Join Us! Imperative Care
Salary Range: $151,000 - 161,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.

The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.

Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.