Physiol
As a
Quality Control Analytical Chemist , you will be responsible for performing analytical testing of incoming materials, in-process samples, and finished materials within a regulated medical device manufacturing environment. You will ensure that materials meet defined specifications and regulatory requirements through accurate chemical analysis, thorough documentation, and close collaboration with internal and external stakeholders.
Key Responsibilities
Perform analytical testing of incoming, in-process, and finished materials using techniques such as HPLC, GC, FTIR, UV-Vis, pH, titration, and conductivity.
Inspect materials visually and dimensionally and approve or reject them based on specifications and test results.
Accurately document analytical results and quality data in quality systems and databases.
Prepare and maintain Certificates of Analysis, Nonconformance Reports, and related quality documentation.
Ensure compliance with GMP, ISO 13485, and FDA regulatory requirements.
Support internal and external audits by providing analytical data and documentation.
Collaborate with internal teams and suppliers on quality issues, root cause analysis, CAPA, and continuous improvement.
Qualifications
Associate or Bachelor’s degree in Chemistry, Chemical Engineering, or a related field.
Minimum 3 years of experience in analytical testing or quality inspection within a regulated industry.
Proficiency in analytical techniques and laboratory instruments such as HPLC, GC, FTIR, UV-Vis spectroscopy, pH measurement, titration, and conductivity testing.
Strong understanding of GMP, ISO 13485, and FDA regulatory requirements.
Ability to interpret technical drawings, specifications, and tolerances.
High attention to detail with strong documentation and communication skills.
Preferred Skills
Knowledge of statistical process control (SPC).
Familiarity with risk management and validation protocols.
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)
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
#J-18808-Ljbffr
Quality Control Analytical Chemist , you will be responsible for performing analytical testing of incoming materials, in-process samples, and finished materials within a regulated medical device manufacturing environment. You will ensure that materials meet defined specifications and regulatory requirements through accurate chemical analysis, thorough documentation, and close collaboration with internal and external stakeholders.
Key Responsibilities
Perform analytical testing of incoming, in-process, and finished materials using techniques such as HPLC, GC, FTIR, UV-Vis, pH, titration, and conductivity.
Inspect materials visually and dimensionally and approve or reject them based on specifications and test results.
Accurately document analytical results and quality data in quality systems and databases.
Prepare and maintain Certificates of Analysis, Nonconformance Reports, and related quality documentation.
Ensure compliance with GMP, ISO 13485, and FDA regulatory requirements.
Support internal and external audits by providing analytical data and documentation.
Collaborate with internal teams and suppliers on quality issues, root cause analysis, CAPA, and continuous improvement.
Qualifications
Associate or Bachelor’s degree in Chemistry, Chemical Engineering, or a related field.
Minimum 3 years of experience in analytical testing or quality inspection within a regulated industry.
Proficiency in analytical techniques and laboratory instruments such as HPLC, GC, FTIR, UV-Vis spectroscopy, pH measurement, titration, and conductivity testing.
Strong understanding of GMP, ISO 13485, and FDA regulatory requirements.
Ability to interpret technical drawings, specifications, and tolerances.
High attention to detail with strong documentation and communication skills.
Preferred Skills
Knowledge of statistical process control (SPC).
Familiarity with risk management and validation protocols.
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)
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
#J-18808-Ljbffr