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LGC · 11 hours ago

Quality Assurance Manager

Alexandria, MN

Full-time

Onsite

Senior Level

$104K/yr - $156K/yr

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. The Quality Assurance Manager will lead the QA operations at the Alexandria site, ensuring product quality and compliance while managing a team of QA staff to achieve quality goals and objectives.

BiotechnologyGeneticsLife Science

H1B Sponsor Likely

Responsibilities

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

In partnership with QA leadership, 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

In partnership with site and functional leadership, 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

In partnership with direct management, develop, execute, and review strategies to improve the effectiveness of local QA procedures, processes, training, 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 effective delivery of QA and QMS training needs and activities across the site

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

Perform other duties as required to meet business needs

Qualification

ISO 9001 knowledgeQuality Management SystemRisk analysisMicrosoft Office proficiencyTeam managementEmotional resilienceStrategic thinkingAttention to detailCommunication skillsProblem-solving skills

Required

Bachelor's degree in an engineering, mathematics, business, or scientific discipline—or equivalent combination of applicable education and relevant work experience

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

Preferred

Prior experience in the medical device, biotechnology, or biopharma industry

Prior experience in an FDA-certified manufacturing environment

Demonstrated experience with electronic platforms for quality management systems

Benefits

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!

Company

LGC

Glassdoor3.3

We are a global leader in life science tools, partnering with customers to find solutions that diagnose, treat, feed and protect our growing population.

Founded in 1996

Teddington, Gloucestershire, GBR

1001-5000 employees

http://www.lgcgroup.com/

H1B Sponsorship

LGC has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2024 (1)