Supervisor, Quality Assurance

Located in Mountain View, CA, the QA Laboratory Supervisor provides leadership to the Quality Assurance Laboratory and Inspection groups.  This role provides training and supervision while managing projects and assigning resources, as required. The QA Laboratory Supervisor develops, implements, and maintains the activities of QA Lab and manages the testing of incoming raw materials, in-process materials, and finished products.    

The QA Laboratory Supervisor is responsible for making recommendations, investigating non-conformances and initiating corrective and preventative actions, when necessary to assure compliance to the Quality Management System.  

Essential Duties and Responsibilities: 

• Supervise activities of QA/QC team to create a positive culture of quality awareness, teamwork, and cooperation with all departments, ensuring departmental and company goals are met. This includes interviewing, hiring, training, mentoring and developing employees’ skills and abilities ; planning, assigning, and directing work; appraising performance; rewarding and disciplining; addressing complaints and resolving problems.
• Actively participate in the development, implementation and maintenance of the Quality System and QA/QC activities; provide support and guidance to product development and product transfer teams; Be a change advocate for continuous improvement through data driven decision making.
• Coordinate QA/QC assignments and generate daily testing schedules.
• Supervise or perform analysis and disposition of incoming raw materials, in-process materials, and finished products.
• Lead or perform root cause analysis activities; Problem Solving by seeking root cause and developing and implementing pragmatic solutions
• Monitor, analyze, track, and trend quality data for Management Review.
• Participate in regulatory audits or inspections.
• Support Regulatory Submissions both Domestic and International.
• Maintain in-house templates used to validate and release product; Review and approve all required documents; Maintain Excel-based macros used for data import, data export, component tracking and Certificate of Analysis generation.
• Perform additional responsibilities as needed, requested, or required.

Position Requirements (Knowledge, skills and abilities required to perform satisfactorily in the position):

• Ability to successfully and positively lead and mentor a team.
• Working knowledge of current Good Laboratory Practices (cGLP)and laboratory and diagnostic equipment.
• Ability to read and understand MBRs, MOPs, SOPs, and Safety Policies in English.
• High level of presentation and communication skills.  Effectively communicate in English (verbal and written).
• Ability to analyze data, summarize results, troubleshoot issues, and identify solutions; Assess the long-term impact of decisions.
• Extensive knowledge of algebra, statistics, weights and measures, and the metric system.
• Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook).
• Detail orientated such that work can be performed timely, accurately and at a consistent level.
• Ability to be self-motivated, enthusiastic, oversee multiple projects simultaneously, meet deadlines and ensure successful and timely product release.
• Anticipate internal and external customer needs, giving high priority to customer satisfaction and service.  
• Ability to collaborate and cooperate with all departments to analyze and resolve issues and ability to work independently with a positive, courteous, and professional demeanor.
• Strong technical skills with ability to understand product function.

Education and Experience:

• Bachelor of Science  in a scientific discipline (Biology or Chemistry). 
• 5-7 years of IVD or Medical Device experience in Quality Systems, Quality Assurance, or Quality Control departments.
• Minimum of 3 years supervisory experience (required)
• Strong understanding of 21 CFR 820, ISO 13485, MHLW Ministerial Ordinance 169 and the IVD Directive

Supervisory Responsibility:

This position has supervisory responsibility

Work Environment:

• Professional Office Environment

• Laboratory Environment

• Potential exposure to chemical/hazardous materials and bio-hazardous waste

• Potential Exposure to a cold room (2-8°C) environment for up to 20 minutes at a time
• Must wear protective equipment such as safety glasses, lab coats, hairnets, hard hats, face shields and any relevant equipment deemed as necessary.

Physical Demands:

• Lifting and carrying up to 30 pounds
• Long periods of sitting or standing (continuously for up to 3 hours at a time and up to 8+ hours daily
• Frequent use of hands (Keyboard, mouse, etc.) for up to 3 hours at a time and up to 8+ hours daily)
• Viewing of Computer Monitor for up to 3 hours at a time and up to 8+ hours daily.
• Perform work in cold rooms for up to 20 minutes at a time
• Ability to visually discern printed characters as small as 1/16”; Close and distant vision

Position type and expected hours of work: 
 Full Time (May need to work nights, weekends and Holidays, as needed)

Travel Demands: 

Limited travel may be required to attend conferences, training, etc.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change, at any time with or without notice, to support company requirements.

Affirmative action plan/equal employer opportunity (AAP/EEO) statement:

Minaris Medical America, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Minaris Medical America, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Disclaimer

The above statements are intended to describe the general nature and level of  work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities. Minaris Medical management reserves the right to amend and change responsibilities to meet business and organizational needs, as necessary.