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SCIEX · 5 months ago

Manager, Quality Assurance & Quality Control

Richmond, Illinois, United States

Full-time

Onsite

Mid, Senior Level

$120K/yr - $140K/yr

5+ years exp

Leica Biosystems is a global leader in cancer diagnostics, committed to advancing cancer diagnostics and improving lives. The Manager, Quality Assurance and Quality Control will lead daily quality operations, oversee inspection and product release activities, and ensure compliance with quality systems and standards.

BiotechnologyManufacturingMedical DeviceProduct Design

H1B Sponsor Likely

Responsibilities

Hire, develop, engage, and retain highly capable QA and QC team members, ensuring that each associate is meeting performance requirements and that each critical position has an identified successor with a targeted and robust development plan

Oversee inspection and product release activities as well as CDT&R, and develop key strategies to support future business success

Coach the team on how to effectively manage and anticipate changing needs for resources and how to flex resource allocation in the face of changing circumstances, including notifying stakeholders and recommending countermeasures to ensure that cross-functional teams and projects are staffed with qualified and skilled QA and QC associates and business needs are met

Manage relationships with relevant cross-functional leaders including participating in Daily Management meetings and effectively communicating issues, risks, and needs to the Leadership team

Plan, prioritize, and coordinate workflow and cross-site/function interactions to ensure on time delivery of product and projects and compliance with quality systems and standards, using advanced knowledge of Danaher Business System (DBS) tools

Ensure site audit readiness at all times through monitoring and learning from past audits, training and preparation of staff and mitigation of risks

Support team in formulating and testing effective data-based strategy for winning against the competition or exceeding expectations as a team

Qualification

Medical device quality systemISO 13485 complianceUS FDA regulationsLean tools knowledgeQuality Management SystemsContinuous improvement methodologiesData analysisNCR knowledgeTeam leadershipCross-functional collaboration

Required

Bachelor's degree or equivalent advanced degree in engineering, science, medical, or technical field and 5+ years' experience with increasing responsibility in medical device/IVD

Experience working within a medical device quality system in compliance with US FDA, ISO 13485 and EU MDR/IVDR regulations

Proven experience in developing and implementing mining tools to monitor product complaint trends including defined control and/or action limits to detect emerging field issues

Track record of collaborating with technical groups to identify product improvement opportunities

Travel requirements < 5% of the time, domestic and international

Overnight travel may be required

Be able to occasionally lift and/or move up to 40 pounds

Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus

This position will occasionally require travel by car and flying in and out of airports with possible long wait times

Preferred

Knowledge of lean tools such as 5S, Standard Work, KANBAN, Policy Deployment, Value Stream Management, Visual Management, SAP etc

Demonstrated knowledge of Quality Management Systems, continuous improvement methodologies, and understanding of manufacturing processes with high mix low volume and high mix high volume environment

Demonstrated ability to lead, develop, communicate, and implement a strategy to ensure compliance to company, regulatory and industry requirements

Experience and/or knowledge of NCRs

Benefits

Paid time off

Medical/dental/vision insurance

401(k)

Company

SCIEX

Glassdoor3.3

SCIEX is a biotechnology company that sells mass spectrometers, capillary electrophoresis, and ion sources products.

Founded in 1970

Framingham, Massachusetts, USA

1001-5000 employees

http://www.sciex.com

H1B Sponsorship

SCIEX 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

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Trends of Total Sponsorships

2025 (1)