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Global Quality Systems Manager

Job in Town of Poland, Jamestown, Chautauqua County, New York, 14701, USA
Listing for: BVI Medical
Full Time position
Listed on 2026-02-01
Job specializations:
  • Quality Assurance - QA/QC
    QA Specialist / Manager, Quality Control / Manager
Salary/Wage Range or Industry Benchmark: 100000 - 125000 USD Yearly USD 100000.00 125000.00 YEAR
Job Description & How to Apply Below
Location: Town of Poland

Purpose

As a Global Quality Systems Manager
, you will lead the global document control and training function, driving the development, deployment, and continuous improvement of global Quality Management System (QMS) programs. You will ensure that global policies, processes, procedures, and controls comply with applicable regulations, standards, and guidelines, including ISO 13485. You will lead quality planning activities, oversee the development and implementation of global policies and procedures, and prepare for and host internal and external audits.

You will facilitate the sharing of best practices, initiatives, and accomplishments across the business to strengthen quality culture and consistency.

This is a remote, second‑shift position
, supporting our manufacturing site in Mexico
, with working hours starting approximately 1:00–2:00 PM (Poland time) to ensure effective collaboration with the site and global stakeholders.

Key Responsibilities
  • Support the Global Quality team and Site Quality teams, including management representatives, to ensure continuous improvement, oversight, and integrity of the BVI Quality Management System
  • Lead globalization and harmonization of the QMS across multiple sites and functions
  • Administer and manage the electronic QMS, including establishing training plans, monitoring completion across the organization, and providing guidance and support on system usage
  • Review, analyze, and report on key quality performance indicators and develop corrective actions for recurring discrepancies
  • Prepare and submit quality metrics and reports to corporate and site quality management as part of the Management Review process
  • Act as a subject matter expert for QMS, training, and regulatory compliance in support of global projects
  • Develop QMS‑related training and raise CAPAs and quality plans to drive system improvements
  • Facilitate audit readiness activities, including coordination of document sharing platforms, awareness briefings, and logistical support
  • Act as SME during internal and external audits for document and record control, general QMS, and training
  • Perform internal audits as part of the global internal audit program, including planning, execution, and reporting within required timelines
  • Host and support external audits, including customer audits, as required
  • Promote awareness of quality, regulatory, and customer requirements across the organization using appropriate change management tools
  • Coordinate and monitor corrective and preventive actions to support continuous improvement of the QMS
Qualification
  • Knowledge of Quality Management System programs and certification standards, including ISO 13485, with the ability to implement, maintain, and improve QMS
  • Minimum 3 years of experience in Quality Assurance or a related role
  • Demonstrated ability to lead teams, manage projects, and cross‑train associates
  • Experience working in a global, multi‑site environment
  • Ability to work remotely on a second‑shift schedule, with availability starting approximately 1:00–2:00 PM (Poland time) to support the Mexico site and collaborate with global teams
  • Strong communication, organizational, and stakeholder management skills
Company

BVI® is refocusing the future of vision.

As one of the fastest‑growing, diversified surgical ophthalmic businesses in the world, our purpose‑built portfolio of trusted brands includes:
Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single‑Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us.

Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at

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