Instrumentation Laboratory Company

Manager, Quality Control

Instrumentation Laboratory Company • $90K — $120K *
Waukesha, WI 53188In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Medical Technology or related field
  • Minimum 10 years of clinical laboratory experience, preferably with In-Vitro Diagnostics
  • At least 5 years of people management experience, ideally in a clinical or GMP environment
  • Demonstrated leadership and strong analytical skills
  • Excellent communication skills, both verbal and written
  • Disciplined and thorough approach to tasks and work product

Responsibilities

  • Lead the Quality Control team with strategic direction and daily leadership
  • Collaborate with cross-functional teams to support product development and quality compliance
  • Ensure adherence to regulatory standards, promoting audit readiness and quality culture
  • Drive continuous improvement and operational efficiency within QC operations
  • Manage departmental budgeting and resource planning, including training and new equipment implementation
  • Set and track performance metrics while presenting findings to governance boards
  • Oversee investigation governance and ownership of OOS, CAPA, and NCR processes

Benefits

  • Collaborative and inclusive team environment
  • Opportunities for professional development and training
  • Participation in strategic decision-making
  • Possibility for flexible work arrangements
  • Engagement with cross-functional teams including R&D and Operations
Full Job Description
Overview

Job Summary

The Manager, Quality Control is a key contributor to the Quality Assurance and Regulatory Affairs (QARA) team for the Transplant Technology Center. Reporting to the Sr. Director Quality Assurance and Regulatory Affairs, this role will be responsible for leading the Quality Control team and all is responsible for all other aspects of the Quality Control Department.

Responsibilities

Key Accountabilities
  • Leads the Quality Control (QC) team, providing strategic direction and day-to-day leadership, including setting clear, challenging, and achieveable SMART goals for the team, aligning individual and department goals with broader business unit strategy, prioritization of work, resource allocation, workforce planning and talent management, including hiring, onboarding, training, performance management to build a high performing team.
  • Partners cross-functionally with Quality Assurance, Regulatory Affairs, Research & Development, Manufacturing Technical Support and Operations to resolve issues, support product development and ensure alignment.
  • Ensures QC team team and site adherence to SOPs, FDA, Regulatory and Compliance (ISO 13485, 21 CFR 820, and MDSAP Requirements) and good manufacturing practices to ensure inspection readiness and audit compliance, while fostering a culture of accountability and quality excellence.
  • Role models and reinforces company values, driving a high performance, collaborative, and inclusive team environment.
  • Drives continuous process improvments and operational efficiency within the department, proactively identifying opportunities to enhance quality, scalability, and effectiveness across QC operations
  • Participates in setting and adherence to the department budget. Coordinates the purchase, training and implementation of new equipment, products, and systems.
  • Sets and tracks department key performance metrics and presents at QRB and MRB.
  • Leads investigation governance within QC, with accountability for OOS, CAPA, and NCR investigations.
  • Authors, updates and reviews SOPs, FORs and TMPs.
  • Represents QC for Validaton Plans, Protocols and PDP projects.
  • Oversees departmental planning and execution, including scheduling, planning, and prioritization of daily work and the QC Stability Program.
  • Participates with technical support issues and coordinates QC resources for investigations.
  • Reviews test results and coordinates QC resources with needed for investigations.
  • Performs other duties and responsibilities as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships
  • Daily interaction with QC Team to support daily activities.
  • Daily interaction with co-workers from Operations to ensure product release priorities.
  • Interaction with Manufacturing Technical Support team in support of product investigations.
  • Interaction with Research and Development to support new products and product improvements.
  • Interaction with Quality Assurance for quality and regulatory compliance.
  • Interaction with Customer Technical Support team in support of customer compaint investigation.


Qualifications

Minimum Knowledge & Experience required for the position:
  • Bachelor's Degree in Medical Technology or a Bachelor's of Science Degree in a related field
  • Minimum 10 years of clinical laboratory experience working with In-Vitro Diagnostics; preferred HLA screening Assay and Elisa products
  • Minimum 5 years of people management experience; preferred people leadership in a clinical setting or GMP environment Strong analytical, communication, and leadership skills
  • Demonstrated leadership skills
  • Excellent verbal and written communication skills
  • Exhibits a disciplined approach to work ensuring thoroughness, consistency, validation, and accuracy in all tasks and work product
  • Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:
  • Effective communication
  • Strong leadership
  • Proactive problem-solving
  • Stategic thinking
  • Organizational skills and time management
  • Coaching skills for improvement and problem solving
  • Continous learning and development mindset
  • Conflict resolution
  • Foster a positive and inclusive work environment

Travel requirements:
Up to 5% annually.

About Instrumentation Laboratory Company

Instrumentation Laboratory Company (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, with a focus on Critical Care and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. IL develops, manufactures and distributes diagnostic solutions including: critical care systems, hemostasis systems and information management systems. IL's products are used in hospitals around the world, including large hospital systems, independent hospitals and clinics, and reference laboratories. IL is headquartered in Bedford, Massachusetts, and has operations in Europe, the Middle East, Africa, Asia-Pacific, and Latin America.
Learn more about Instrumentation Laboratory Company
Size
1,000 employees
Industry
Healthcare
Net Income
$50 million
5 Year Trend
+5%
Revenue
$500 million
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Instrumentation Laboratory Company

More Pharmaceuticals & Biotech Jobs

Find similar Manager, Quality Control jobs:

NationwideWaukesha, WI