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 is strongly preferred.
• Prior experience in an FDA-certified manufacturing environment is strongly preferred.
• Prior experience managing the quality assurance function, or a related product quality function, and delivery of associated operational processes within an ISO-certified quality management system and manufacturing environment
• Proven success managing and developing business staff, with the demonstrated ability to effectively manage and direct a team in a dynamic working environment
• Proven expert knowledge and understanding of the ISO 9001 standard, or a relevant ISO quality standard
• Demonstrated experience performing risk analyses (e.g. FMEA, FTA, Risk Ranking/Filtering) and cross-functional root cause investigations throughout the product manufacturing lifecycle
• Proven success directing and chairing large-group engagements, such as customer or supplier audits, ISO (re)certifications, and company management reviews
• Proficient computer skills, including working knowledge of Microsoft Office suite of products, particularly Word, Excel, and PowerPoint
• Demonstrated experience with electronic platforms for quality management systems

Additional Information

What we offer (US based-employees):

• Competitive compensation with strong bonus program
• Comprehensive medical, dental, and vision benefits for employees and dependents
• FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
• Deductible Buffer Insurance and Critical Illness Insurance
• 401(k) retirement plan with matching employer contribution
• Company-paid short- and long- term disability, life insurance, and employee assistance program
• Flexible work options
• Pet Insurance for our furry friends
• Enhanced Parental leave of 8 additional weeks
• PTO that begins immediately
• Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more!

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.