Head of Quality and Regulatory

Job Description

• Responsible for establishing and maintaining company-wide post-market surveillance (PMS) of the end-to-end sales process of TruGraf, i.e. from sales and marketing, through inventory/product management, ordering phlebotomy kits, scheduling of blood draws, sample logistics, laboratory workflow and resulting to physicians
• Ensure company-wide operations are in compliance with all relevant regulatory and accreditation agencies in collaboration with the Clinical Laboratory Manager and/or Clinical Laboratory Director, e.g. NYS, CAP, CLIA, ISO-13485, ISO-15189
• Ensure every audit from every recognized authority is passed without disruption to business operations
• Implement as 'Owner' and maintain a Customer Complaint Handling System for Post-Market Surveillance (PMS) with appropriate CAPA (Corrective Action and Preventative Action) processes using the Eurofins ETQ software
• Lead the administration of the clinical laboratory's internal and external proficiency testing programs, including collation of data and ensuring review of results and corrective action, as applicable
• Lead in investigations to determine the RCA (root cause analysis) of reportable quality events, TNPs, client complaints, revised reports company-wide, ensuring that responses are accurate and complete, as well as ensuring that immediate, short-term, and long-term corrective actions are implemented
• Lead equipment maintenance program to ensure instruments are qualified and calibrated in an accurate, timely manner
• Manage and maintain the Company's quality inspection and product release program for incoming and in-process materials and components; ensure only qualified in-house or manufactured reagents are in use; work with purchasing staff to establish quality requirements from external suppliers; assess the product specifications of the company and of its suppliers
• Ensure all necessary change control provisions are followed as software, equipment and other elements of the clinical operations are upgraded, including documentation that supports the submission of TGI tests through the MolDx process
• Lead the clinical laboratory in follow up investigation of TNPs or QC problems, as needed
• Lead the defining, monitoring, and reporting department quality indicator and improvement metrics and documenting appropriate follow up when metrics do not meet defined parameters
• Lead the implementation of all QA/QC policies to ensure department and company compliance and ensure compliance. Perform department quality related activities
• Identify company-wide quality-related training needs and develop the appropriate quality related training materials and trainers
• Consistently notifies Executive Team of possible compliance and/or technical issues and suggests/implements corrective actions
• Leader of the Laboratory Quality Committee
• Ensure continuous quality improvement by collaborating with management to implement standardization and process improvement with the department
• Provide information to, and respond to questions from, associates about quality-related issues
• Consistently demonstrates a high level of initiative and problem solving ability
• Coordinates efforts to effectively work with others in a way that is productive and promotes teamwork and change
• Ability to partner directly with department managers to assist them in carrying out their responsibilities
• Projects a positive, professional demeanor at all times
• Perform other duties as assigned by the Clinical Laboratory Director
• Represent department and the organization favorably and in accordance with established Company standards and associate attributes at all times

Qualifications Essential Knowledge, Skills and Abilities:

• Bachelor's degree or higher in a chemical, physical, biological, or medical laboratory technology (MT/CLS with certification, i.e. ASCP is preferred)
• 5 years experience in a high complexity setting
• 5 years of experience with clinical laboratory Quality Assurance, Quality Control or Quality Improvement
• 5 years previous experience in a leadership position
• Experience with laboratory regulations and accreditation standards are required
• Understands clinical laboratory operations
• Able to effect Quality Improvement through problem solving skills and knowledge of quality tools
• Ability to prioritize and decide appropriate course of actions
• Strong interpersonal communication skills
• Ability to interact with associates at every level
• Demonstrated strong writing and composition skills
• Keen attention to detail
• Proficient use and skill of PC based software programs
• Willing to work outside normal business hours as job dictates
• Ability to make independent decision regarding matters of significance

Physical Requirements

• Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead
• Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting
• Ability to continuously operate a personal computer for extended periods of time (4 or more hours)
• Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgments and decisions

The essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Additional InformationPosition is Full Time, Monday-Friday, 8am-5pm

Candidates currently living within a commutable distance of Fremont, CA are encouraged to apply.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.