Quality Engineer (Ophthalmic Medical Device Manufacturing)

BVI Medical, Inc.; Sarasota (FL); On-site; USD 70,000 - 105,000; Full time

Job summary

BVI Medical, Inc. is seeking a Quality Engineer to support ophthalmic medical device manufacturing from development through production.

You will design and execute validation/qualification tests on processes, equipment, and software to ensure compliance with ISO 13485 and FDA regulations. The role requires a bachelor’s in Engineering or Biomedical Engineering and at least two years of related experience, with hands-on CDS software and QMS tools like EtQ or TrackWise.

Qualifications

• Bachelor's degree in Engineering or Biomedical Engineering.
• 2+ years of quality and validation support in medical device R&D/manufacturing.
• Experience with CDS software, CAPA, and quality events using EtQ or TrackWise.

Responsibilities

• Provide quality and validation support to R&D of ophthalmic medical device manufacturing processes and products.
• Ensure product quality throughout manufacturing from design to delivery.
• Lead CAPA investigations and manage CAPA workflows with EtQ or TrackWise.

Skills

CAPA

EtQ

TrackWise

CDS

IQ/OQ/PQ

Quality Systems

Education

Bachelor's in Engineering / Biomedical Engineering

Tools

LabWare LIMS

Water Empower

Job description

Purpose

Quality Engineer (Ophthalmic Medical Device Manufacturing)

Key Responsibilities

• Provide quality and validation support to the R&D of medical device manufacturing processes and products.
• Ensure the quality of ophthalmic medical device products manufacturing throughout the manufacturing process, from design and development to production and delivery.
• Conduct validation and qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
• Lead investigations into non-conformances and implement corrective and preventive actions. Manage CAPA workflows, quality event investigations, and equipment evaluation reviews using EtQ OR TrackWise quality management software systems.
• Design and document validation protocols for high-speed mounter machine and autoclave equipment and processes to ensure consistency in internal and external production qualification standards.
• Create Triennial Periodic Review validation reports, incorporating CAPA, change control, deviation history, calibration, and maintenance records. Analyze validation test data to determine whether systems and processes have met validation criteria and to identify root causes of production problems.
• Ensure compliance to medical device industry regulations, including ISO 13485, FDA 21CFR Part 820, FDA 21 CFR Part 11, ISO 14971, and ISO 11135 / ISO 11137.
• Develop and maintain quality systems and processes to ensure compliance with FDA regulations and international standards. Participate in regulatory inspections and provide support for product registrations and submissions.
• Utilize chromatography data system (CDS) software packages to validate or characterize sustainable biotechnology products, such as Water Empower or LabWare LIMS electronic testing platform.
• Design and execute IQ, OQ, and PQ validation protocols, ensuring equipment and software systems meet internal quality standards and industry regulatory requirements.
• Collaborate with cross-functional teams to identify and implement continuous improvement initiatives to enhance product quality and reduce manufacturing costs.
• Prepare, maintain, and review paper-based validation and compliance documentation framework for ophthalmic medical device manufacturing.
• Develop and implement quality plans and procedures for production processes, including inspection and testing methods and statistical process control.
• Provide guidance and training to manufacturing and quality assurance personnel on quality systems and procedures.
• 10% international travel required to conduct hands on audits of products and processes.

Qualification

• Candidate must have a bachelor's in Engineering or Biomedical Engineering and 2 years of experience in providing quality and validation support to the R&D of medical device manufacturing processes and products.
• Experience must include: Utilizing chromatography data system (CDS) software packages to validate and characterize sustainable biotechnology products; Managing CAPA workflows, quality event investigations, and equipment evaluation reviews using EtQ OR TrackWise quality management software systems.; Creating Triennial Periodic Review validation reports, incorporating CAPA, change control, deviation history, calibration, and maintenance records.; Ensuring compliance to medical device industry regulations., including FDA 21 CFR Part 820 and/or ISO 13485.; and Designing and executing IQ, OQ, and PQ validation protocols, ensuring equipment and software systems meet internal quality standards and industry regulatory requirements.
• 10% international travel required to conduct hands‑on audits of products and processes.

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 www.bvimedical.com