Participates with senior management to establish strategic plans and objectives for the Quality Department. Makes final decisions on implementation and ensures operational effectiveness. Effectively cascades functional strategy and contributes to development of organizational policies. Develops a strong culture of quality within the entire Covaris organization. Participates in the development of regulatory objectives and liaises with necessary outside or inside stakeholders.
Essential Responsibilities: The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.
- Further develop and drive changes to a Quality Management System (QMS) that is compliant, effective, and quickly responds to the needs of a diverse and evolving product line
- Lead the organization and QMS to ISO certification and accommodate FDA level design and manufacturing
- Help guide decisions about regulatory strategies for sample preparation/pre-analytic products with personal experience or work with consultants/contractors
- Manage a group QA/QC professionals and mentor, motivate, and organize the teams
- Manages quality assurance, quality control, supplier quality, incoming inspection, non-conformance, CAPAs, calibration, complaint handling, and document control for an instrument, consumable, and reagent manufacturing facility
- Plan, coordinate and direct quality strategies for new and existing products, including raw materials, materials in process, and finished goods
- Ultimately responsible for driving investigations and implementing corrective actions to resolve any complaints/ non-conformance/CAPAs
- Be comfortable working with employees from all departments and interfacing with customers regarding our quality polices and how they apply to our complex and technical product line
Non-Essential Responsibilities: In addition to the essential responsibilities listed above, the employee may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.
Qualifications:
- Bachelor’s degree in Science or Engineering
- 10+ years quality systems/regulatory compliance experience, preferably with in-vitro diagnostics or Life Sciences
- Experience with laboratory instrumentation, consumables, and/or reagents is a plus
- 5+ years managing a quality organization with a diverse product portfolio
- Expertise with ISO 9001 and GMP standards and practices
- Experience with and ability to develop process within an electronic quality management system (eQMS)
- Ability to implement, prioritize, and direct multiple projects simultaneously
- Demonstrates leadership ability and has excellent people management skills
- Strong written and verbal communication skills
Reasonable Accommodation: Covaris is committed to the spirit and the letter of the Americans with Disabilities Act. All requirements are subject to possible modification to reasonably accommodate otherwise qualified individuals.