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.