Quality Assurance (QA) Manager - Engineering

Company Description

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Our high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality and range.

Our tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimize food production; and continuously monitor and enhance the quality of food, the environment and consumer products.

LGC’s 175+ years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community.  Join us and help us achieve our mission of Science for a Safer World! 

Job Description

The Quality Assurance (QA) Manager will serve as the QA leader of the Company’s operational site, in Alexandria, MN, dedicated to the successful delivery of site quality goals and objectives. This individual leads the daily operations of a team of QA staff responsible for confirming satisfactory product design verification, validation, and transfer; documentation control for release of commercialized product; suitability of local quality management system (QMS); change and risk management; corrective and preventive actions; complaint resolution and root cause investigation; monitoring and reporting of relevant data and metrics.

As directed by leadership, this individual may direct QA operations for more than one operational site. This role is expected to serve as the primary QA business partner to site-focused teams within the Manufacturing, Supply Chain, EH&S, Commercial, Product Management, R&D, and Customer Service functions, among others. 

This role is located at our operational site in Alexandria Minnesota.

• Provide daily leadership to a team of direct reports in the areas of safety, efficiency, quality control, cost, resources, and engagement in support of the organization’s commercial and operational activities.  
• Responsible for personnel activities of direct reports including business objective setting, staffing, resource planning, training, performance management, and staff development and effectiveness. 
• Ensure effectiveness of local quality management system (QMS), while also ensuring the highest standard of product quality and site compliance with applicable regulatory and customer requirements.                                                                                                                                   
• Support the development, implementation, and scaling of global and local QMS, in alignment with best practices and business needs, across the site functions.  
• Serve as Quality Management Representative for operational site(s) under direct remit, including hosting third-party inspections and audits and chairing periodic management reviews of the QMS. 
• Develop and implement key performance indicators (KPI’s) relevant to the site QMS and QA function; oversee the regular review, analysis, and reporting on KPI’s for team(s) and area(s) under direct remit. 
• Ensure high-quality data delivery and effective communication to customers, internal or external.
• Develop, execute, and review strategies to improve the effectiveness of local QA procedures, processes, and business reporting.  
• Ensure effective delivery of, and timely resolutions resulting from, local operational processes which include document and change control; corrective and preventive actions (CAPA’s); manufacturing non-conformance; risk management and business continuity; complaint resolution; root cause investigations; quality standard certification and maintenance; product design verification, validation, and transfer. 
• Oversee the QA and QMS training needs and activities across the site, drive enhancements to training approaches and systems. 
• Serve as business partner, with the relevant subject matter expertise, to local leaders and functional stakeholders . 
• Support deployment of global practices and platforms; may lead global projects as directed.

Qualifications

• Bachelor’s degree in an engineering, mathematics, business, or scientific discipline—or equivalent combination of applicable education and relevant work experience 
• Prior experience in the medical device, biotechnology, or engineering industry