Integra LifeSciences · 1 day ago
Quality Systems II Engineer
Mansfield, MA
Full-time
Onsite
Mid Level
$71K/yr - $98K/yr
3+ years expIntegra LifeSciences is dedicated to changing lives and shaping the future of healthcare. The Quality Systems II Engineer is responsible for supporting the Quality Management System (QMS), ensuring compliance, driving improvements, and providing quality assurance support to various teams. This role involves training on QMS processes, managing audits, and promoting continuous improvement initiatives.
BiotechnologyMedical DeviceHealthcareLife ScienceHealth CareMedical
Responsibilities
Supports maintenance of the Quality management System, ensuring compliance with regulations and internal site and global procedures. Identifies gaps in the QMS and drives improvements to close gaps
Maintains the Quality Manual and site Quality System related procedures, ensuring contents are compliant and appropriate for the business
Identifies Noncompliance's, works with complaint handling, and CAPA Investigations
Organizes and manages the plant internal audit system as the site Internal Audit Manager
Supports external Quality System audits in key roles. Provides support and subject matter expertise during audits and inspections
Assists in the initiation, processing, and completion of CAPA records in the electronic system
Leads meetings and communications for CAPA updates, information, and concerns to keep CAPA timelines on track
Responsible for collecting and reporting Quality Metrics on regular basis in accordance with established procedures
Independently investigates, gathers data, and performs preliminary data analyses
Reports on Key Performance Indicators to adhere to process and prevent occurrence of any non-conformity relating to product, process, or system
Provides experienced quality assurance support to manufacturing, product development teams, procurement, and other functional areas
Promotes the use of customer preferred techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), and Measure System Analysis
Keeps up with current and developing manufacturing and engineering trends that concern product quality
Undertakes special projects as required and contributes to continuous improvement activities
Supports and lead process improvement activities
Writes reports and presents progress at project meetings
Achieves goals within established budgets
Plans projects or subtasks so they may be tracked and presented
Attends various meetings and actions/communicates instructions and follow-ups
Independently determines approach for completion of assigned tasks
Coordinates and leads Quality Review meetings
Communicates confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues
Qualification
Required
Bachelors in an engineering discipline recommended (Mechanical Engineering preferred) with minimum of 3 years' experience in the medical device or pharmaceutical industry; strong analytical skills, exceptional writing and interpersonal relationship skills or combination of relevant work experience and education
Previous CAPA and/or quality systems/assurance experience and demonstrated use of quality tools/methodologies
Detailed knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and other global regulations and standards
Previous experience in high volume manufacturing environment.(Medical Device preferred)
Demonstrated project management and leadership skills, including the ability to lead cross-functional project teams and resolve quality related issues in a timely and effective manner
Strong verbal and written communication skills with the ability to communicate effectively at multiple levels of the organization
Demonstrated organizational skills with the ability to multitask, prioritize and meet deadlines
Must be able to read and write in English
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
H1B Sponsorship
Integra LifeSciences 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
2025 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
EIN Presswire
2026-02-02
2026-01-23
Company data provided by crunchbase