/ Omniome hiring Director, Quality Assurance in San Diego, CA, US

Director, Quality Assurance

Omniome

San Diego, CA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 01/06/2021
  • Website: omniome.com
  • Company Address: 10575 Roselle Street, San Diego, CA, 92121

About Omniome

Based in San Diego and founded in 2013, Omniome is a biotechnology company developing a proprietary DNA sequencing platform capable of delivering unsurpassed sequencing accuracy. Backed by leading life sciences venture investors and a proven management team, Omniome’s vision is to be the most trusted DNA sequencing platform and leader in clinical sequencing. We are a quality-focused, start-up environment where development thrives. Our culture is inspiring, fun and consists of a talented team of ind

Job Description

POSITION SUMMARY:

We are seeking a highly motivated and engaged, experienced Director of Quality Assurance to support the company as it transitions to a commercial entity.  The ideal candidate will use their sharp business mind, attention to detail, and proven experience building, managing and scaling a Quality organization based on strategic business requirements.

ESSENTIAL FUNCTIONS:

  • Build, develop and lead a highly motivated Quality team, establishing and actively managing performance expectations, and providing training and development work to achieve the company’s Quality initiatives
  • Setup and manage project improvements/standardization across the company by creating and continuously improving our Quality Management System
  • Manage QA/QC for instrumentation, software, consumables and reagent manufacturing
  • Influence and build strong working relationships across Omniome organizations and departments and engage with business partners to define system gaps and future requirements for Quality Management Systems
  • Drive the continuous improvement of Omniome’s Quality Management Systems (QMS), including assuring effective management reviews, complaint handling (CRB), Doc Control/change control, Quality Review Board (QRB), QC infrastructure, internal auditing, R&D transfers, validation, and manufacturing support.
  • Ensure company-wide training is effective and that all sites operate within the required quality guidelines
  • Support and influence the commercialization of New Product Introductions by working with Omniome’s core project teams
  • Ensure Omniome’s business practices and development strategies are compliant to applicable regulations
  • Lead executive level quality management reviews
  • Operate as a leader during compliance audits from FDA, ISO 13845, Internal auditors, and customers
  • Responsible for accomplishing results through the management of multiple Omniome teams as well as senior professionals
  • Exercises control over resources, policy formulation and planning
  • Develop and lead a Standard Operating Procedure team within Omniome

EDUCATION, SKILLS, & EXPERIENCE:

  • 10+ years of Quality industry and regulatory roles; Life science tools, medical device or instrumentation experience required
  • Demonstrated experience working with external and commercial teams creating strategies that address customer needs, product compliance and specification
  • Experience leading an in-house Quality Management System, required
  • Excellent negotiation, interpersonal and communication skills
  • Strong problem-solving, strategic-thinking, and critical analysis ability; able to make effective decisions and execute an appropriate course of action that complies with quality and regulatory requirements while supporting business objectives
  • Establishes organizational standards. Leads and sponsors organizational, process improvement, and cross functional development
  • Interprets, executes and recommends modifications to organizational policies
  • Ability to travel 10-20% time both domestically and internationally
  • Ability to deliver strategic business insights in a dynamic environment
  • Organized and detail oriented

ATTITUDE & ATTRIBUTES:

  • Strong customer service and communication skills, both written and verbal
  • Motivated individual and quick learner with desire to learn and grow in a fast-moving environment
  • Data driven decision making
  • Unquestioned integrity and good judgement
  • Thrives in a dynamic, fast- paced environment
  • Ability to thrive and work cross-functionally and manage information requests across multiple groups
  • Positive attitude and team player

PHYSICAL REQUIREMENTS:

  • This position involves mostly computer related work with minimal additional physical requirements. 

Related Jobs

Systems Integration Engineer

Omniome - San Diego, CA, US

Manufacturing Lab Associate

Omniome - San Diego, CA, US

Sr. Bioinformatics Scientist

Omniome - San Diego, CA, US

Software Test Engineer

Omniome - San Diego, CA, US

Software Engineer

Omniome - San Diego, CA, US
Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.