Quality Assurance Manager

at Lucigen Corporation (view profile)
Location Middleton, WI
Date Posted May 5, 2019
Category Biotechnology
Job Type Full-time
Address 2905 Parmenter St

Description

Quality Assurance Manager

Lucigen, now a part of LGC, Biosearch Technologies, is looking for a Quality Assurance (QA) Manager to join our Middleton team. The Quality Assurance Manager is responsible for maintaining, monitoring and improving the processes and support processes for product realization in collaboration with process owners and in compliance with site and divisional quality systems. Some of these processes include product design verification, validation, and transfer; production, quality control (QC), batch record review and release; supplier qualification and monitoring; process and test method validation; and process changes. Support processes include complaint and nonconformance management, internal audit, risk management, document control, quality records management, and corrective action and preventive action. The QA Manager will provide technical leadership within the quality discipline, driving adherence to quality standards and systems and maintaining high levels of customer focus.

The QA Manager will have responsibility to meet or exceed the LGC Genomics business unit objectives as follows:

Primary Duties & Responsibilities

  • Manage the QA department and the execution/improvement of its quality management system (QMS) responsibilities to support the organization's commercial and development activities, while also ensuring compliance with ISO13485 and applicable regulatory standards
  • Provide leadership to QA staff in establishing career development and appropriate training plans in the quality discipline and in enhancing skills in data analysis, risk management approaches, and investigations for root cause determination
  • Responsible for personnel activities of direct reports including: budgeting, staffing, training, performance evaluations, and goal setting including setting employee objectives linked to business initiatives and other key performance indicators
  • Remain current and proficient with quality regulations and guidelines, advising the management team of the business implications of any changes
  • Conduct or direct internal and external audits and evaluations per QMS requirements
  • Maintain technical and analytic standards applicable to our products
  • Responsible for maintenance of document control, including release and changes (develop of structure and content, review and approval), for all QMS-related documentation such as quality manual, standard operating procedures, device master record (including test methods) and batch history records
  • In cooperation with Operations and R&D leadership, ensure the effective management of the design control process with special emphasis on risk management and design transfer activities
  • In cooperation with Operations leadership, ensure the effective management of the supplier qualification and monitoring process

Minimum Qualifications

  • Bachelor's degree in life sciences, engineering, quality, operations management or other applicable degree with life sciences experience
  • 10+ years' experience in the life science industry with preferred emphasis in the regulated life sciences (e.g. in vitro diagnostics or medical device)
  • 7+ years' experience in a quality function and in a supervisory or management capacity
  • Must have a demonstrated track record to lead, manage, and motivate team members through direct line management or influence
  • Must have strong knowledge and experience in risk management, especially as applied to process change and design change management
  • Demonstrated experience in performing risk analysis (e.g. FMEA, FTA, Risk Ranking/Filtering) throughout the product lifecycle and a strong base for applying risk management throughout QMS in alignment with ISO 13485:2016
  • Extensive analytical problem solving skills, strong knowledge in supporting site validation master plan
  • Demonstrated understanding of Lean manufacturing concepts preferred
  • Proven project management skills
  • Demonstrated excellent verbal and written communication skills, comfort interacting with senior internal and external personnel on plant processes, projects and investigations
  • Strong computer skills required including Microsoft Word, Excel, Visio, PPT, and Project
  • Ability to work well in a team environment, possess an ability to adapt to change in the environment, and have proven ability to exert influence in a directive and positive manner

Interested candidates should click here to apply online for this job.

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