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Exact Sciences · 14 hours ago

Lead Quality Assurance Engineer

US - WI - Madison

Full-time

Onsite

Senior Level, Lead/Staff

$112K/yr - $190K/yr

5+ years exp

Exact Sciences is a company focused on changing how the world prevents, detects, and guides treatment for cancer. The Lead Quality Assurance Engineer will provide support to various operational teams, ensuring compliance with quality standards and driving process improvements across the organization.

BiotechnologyHealth DiagnosticsManufacturingMedical

No H1B

Responsibilities

Represent Quality on a variety of projects as assigned

Communicate and collaborate with business partners to ensure robust materials, products, processes, and systems and compliance to procedures and specifications

Create documentation and records in the Electronic Quality Management System (EQMS)

Perform risk assessments and provide risk mitigation strategies

Implement processes to monitor product and process performance, compliance, and reliability

Implement, conduct, and report on process quality programs using statistical data analysis

Review and approve documentation related to Exact Sciences products

Conduct periodic reviews of Quality System documentation

Generate and distribute Quality metrics as assigned

Generate, prepare, and issue data for assigned quality plans

Conduct internal and/or supplier audits to drive process standardization and continuous improvement as required by assigned role

Conduct root cause analysis and corrective and preventive actions

Partner with various teams with timely investigation and resolution of issues to minimize/prevent business disruptions

Design Transfer & Manufacturing Support Assignments also include: Lead and assist Operations in the generation, execution, and review of process, test method, and facility qualification/validation and process improvement projects

Provide Operations support for Investigations, Out-of-Specifications, Nonconformances, Deviations, and material release

Escalate issues when intervention or a change is necessary

Excellent oral and written communication skills

Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork

Support and comply with the company’s Quality Management System policies and procedures

Regular and reliable attendance

Ability to collaborate and work effectively in change and exception management

Ability to frequently and accurately communicate with employees and supporting functions in person, via the telephone, or by email

Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities

Ability to comply with any applicable personal protective equipment requirements

Ability to travel up to 15% of working time away from work location, may include overnight/weekend travel

Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day

Qualification

Quality Management SystemProcess ValidationRisk ManagementSupplier ManagementISO 13485CGMPStatistical Data AnalysisElectronic Quality Management SystemCommunicationTeamworkProblem SolvingCollaboration

Required

Bachelor's degree in a Science or technical field; or Associate's degree in Science or technical field and 2 years of relevant experience as outlined in the essential duties in lieu of a Bachelor's degree

5+ years of experience in quality principles and practice including experience in assigned area (Design Control, Supplier Management, Risk Management, etc.)

Design Transfer assignments require 8+ years of experience in process validation principles and practice

Manufacturing Support assignments require 8+ years of experience in a manufacturing operation environment

Demonstrated ability to successfully work within an CFR 820, ISO 13485, ISO 9001, and/or cGMP structured environment

Authorization to work in the United States without sponsorship

Demonstrated ability to perform the Essential Duties of the position with or without accommodation