Clinisys is a global provider of intelligent diagnostic informatics solutions and expertise designed to redefine the modern laboratory, across healthcare, life sciences, and public health. Millions of diagnostic results and data insights are generated every day using Clinisys’ platform and cloudbased solutions in over 3,000 laboratories across 34 countries. Headquartered in Tucson, Arizona, and Woking, England, Clinisys’ mission is to enhance the effectiveness of diagnostic workflows in any laboratory or testing environment and keep citizens and communities healthier and safer.

Purpose:

Senior Quality Analyst will be the owner of the nonconformance and Corrective and Preventive Actions (CAPA) processes, initiate, manage all company CAPA, lead cross-functional teams to drive for root cause analysis, host appropriate and efficient meetings, establish and manage timelines for timely closure and completion of nonconformances and CAPA, manage continuous improvement initiatives across the company. They will provide guidance for the improvement of the Clinisys Quality Management System including business processes, products, software systems, training and reporting of metrics and trends in accordance with internal and external regulations, policies, and procedures. The Senior Quality Analyst will also plan and execute internal audits.

Essential Functions / Job Responsibilities:

• Own, administer and update, as appropriate, the nonconformance and CAPA processes
• Author nonconformance and CAPA reports in a timely manner
• Train organization on nonconformance and CAPA procedures and expectations
• Write and update SOPs, procedures, work instructions, quality and control plans, risk plans, and notifications
• Collaboration with Subject Matter Experts (SMEs) and associated departments in support of process improvement/enhancement activities
• Monitor nonconformance and CAPA procedures, and any other quality systems as necessary, through trending analysis, compiling metrics and developing reports on a regular basis in support of Management Reviews, CAPA, and improvement initiatives
• Participate in and provide guidance to change management and product development
• Provide training to End Users on the enterprise quality management solution and various workflows (e.g. CAPA process, record content, and software use)

• Communicate with regulatory authorities and customers when required

• All other duties and responsibilities as assigned

Skills needed to be successful:

• Analytical skills that include trending and evaluation of data with the ability to identify potential process problems.
• Team (matrix) leadership across global, various company departments.
• Mastery of investigational tools for successful root cause analysis.
• Organizational, planning, project management and process improvement skills.
• Knowledge of industry regulations and standards.
• Independent and self-driven to excellence.
• Experience with auditing, quality tools and process improvement techniques. ·
• Excellent oral and written communication skills.
• Excellent problem-solving skills
• Strong detail orientation

Required Experience & Education:

• Bachelor’s degree or equivalent
• 10 years’ quality assurance experience in a regulated industry
• Experience with Healthcare Software

Preferred Experience & Education:

• Quality or Regulatory Certifications (RAC, ASQC)
• 3 years of CAPA and root cause investigation experience is preferred

Supervisory Responsibilities:

• None

Onboarding

As part of our onboarding process, all new employees will be required to attend / travel to the office on their first day of employment. This requirement is essential for onboarding activities, including the identity verification, completion of necessary documentation, receiving your IT equipment, introductions to key team members, and orientation to Clinisys policies and procedures.

Perks of working for Clinisys:

From our business casual dress policy, generous holiday/leaves plan and flexible work schedules, to our mission driven organization that supports those who support healthcare organizations, Clinisys promotes work-life balance for all our employees. We place emphasis on training and development, encourage promotion from within and encourage cross-functional team participation. These ideals together foster a culture of professional growth and development for our employees.

Physical Requirements:

• Work is performed in a normal office setting with minimal exposure to health or safety hazards, prolonged periods of sitting at a desk and working on a computer.
• Travel may be required.

Clinisys’s Commitment to Equal Opportunity:

Clinisys is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law.

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General Guidance:

This job description is meant to provide an accurate depiction of tasks and accountabilities that are most often associated with this role. While we strive to provide an accurate depiction, nothing in this description restricts the company from changing, reassigning, expanding or reducing the scope of accountabilities and is subject to change at any time.