Director Quality Engineering

1 week ago

Campbell, United States Imperative Care Full time

**Job Title: Director Quality Engineering**
**Location**_: This position is based in our Campbell, California offices. This position is on-site and full-time _

**Why Imperative Care?**
Do you want to make a real impact on patients? Imperative Care is changing the way stroke is treated. As part of our team, you’d be developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do.

**What You’ll Do**
This position is responsible for the strategic leadership of the Quality Engineering functions at Imperative Care. Contributes to and supports company priorities for new product introduction, manufacturing, and supplier controls to deliver state of the art product quality and reliability. Includes operational leadership relative to defining and implementing quality engineering principles and processes that facilitate the realization of Imperative Care’s business objectives.
- Provide leadership and direction to the quality engineering team to ensure continued conformance to applicable domestic and international regulatory standards for medical device manufacturing
- Builds and maintains a strong and sustaining relationship with Production, Engineering, Regulatory, external Regulatory bodies, and others and will be recognized as a champion of quality engineering principles for the organization
- Continuously foster and drive a continuous improvement approach to Quality, ensuring that quality is the responsibility of everyone through collaborative partnerships across the organization
- Support third party (Notified Body, FDA, etc.) and internal audits
- Responsible for regular assessment and oversight to effectively identify quality and compliance issues, actively resolve issues, recommend solutions, and provide Quality Engineering guidance across functions
- Champion continuous improvement activities within the quality engineering organization with a patient-centric focus to drive increased product quality and performance
- Support new product development and sustaining efforts driving critical strategies for Sterilization, Microbiology, and Biocompatibility
- Review, analyze, and interpret quality performance metrics for quality systems to identify early warning trends of negative performance and report status at Management Review meetings
- Promote new technology implementation/methods/systems/tools to improve overall quality and efficiency
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices
- Provide direction and leadership to Quality staff, including hiring, development, and ongoing performance management of staff
- Committed to developing people and is recognized as an expert in mentoring and coaching individual and team performance while visibly demonstrating the core values of Imperative Care in everyday leadership
- Lead resource planning efforts to ensure quality staff across specialties is sufficient to support the growth of the business
- Partner with cross-functional peers to identify and negotiate implementation of solutions for complex quality problems

**What You’ll Bring**
- Bachelor’s Degree in a related field or 10+ years of increasingly responsible experience in related fields and industries such as medical device or biotechnology
- 4+ years of direct people management experience required
- Thorough knowledge of FDA regulations EU regulations and ISO standards
- Ability to manage complex projects simultaneously
- Proven ability to create improvements in processes and systems
- Possesses excellent leadership and managerial skills and the ability to be very flexible, adaptable and to work under pressure.
- Excellent verbal, and written communication skills
- Effective interpersonal skills
- Proactive leader who can determine deficiencies, communicate them effectively through the organization, and follow through to resolution
- Ability to work effectively with employees at all levels of the organization
- Willingness to perform “hands-on” troubleshooting and problem-solving activities

**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.

Salary Range: $213,000-226,000 annually

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