CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.
CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families.
We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO).
CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians.
More information can be found at .
Oversee daily operations of the QC testing laboratory.
Ensure compliance with ISO 17025 and 13485 standards and regulatory requirements.
Develop and implement laboratory policies, procedures, and quality management systems.
Manage and coordinate laboratory schedules and workflow.
Provide coaching to the laboratory staff and ensure high performance, engagement, and motivation.
Perform all management responsibilities including teams' development, hiring, performance management, compensation, among others.
Foster a culture of continuous improvement and professional development.
Ensure all staff are adequately trained in relevant procedures and safety protocols.
Implement and monitor quality control measures to ensure accuracy and reliability of test results.
Conduct regular audits and inspections to maintain compliance with ISO 17025 and other relevant standards.
Investigate and resolve quality issues and non-conformities.
Provide technical guidance and support to laboratory staff.
Stay current with advancements in QC testing methodologies, technologies, and regulatory requirements.
Ensure accurate and timely documentation of all laboratory activities and test results.
Prepare and present reports on laboratory performance, quality metrics and compliance status.
Maintain laboratory records in accordance with ISO 17025 standards.
Oversee maintenance, calibration, and validation of laboratory equipment.
Manage laboratory inventory, including reagents, supplies, and materials.
Ensure proper storage and handling of all laboratory materials.
Work closely with cross-functional teams, including manufacturing, quality assurance and regulatory affairs.
Represent the laboratory in audits and inspections by regulatory agencies and clients.
Maintain the QC validation master plan to ensure activities are executed and reported timely.
Oversee the qualification and validation activities for the quality control department.
This involves coordination, review and approval of protocols and reports for the qualifications/validations related to the analytical equipment and methods for the QC lab.
Drive continuous improvement activities.
Participate and/or lead CAPA, NCMR processes DMAIC problem solving activities.
Perform other tasks as directed by management.
Measures of performance: Accuracy and reliability of test results Percentage of test results that pass quality audits Number of errors or inaccuracies in test results Timeliness and efficiency Turnaround time for sample testing and reporting Percentage of tests completed within the designated timeframe Compliance and Quality Assurance Number of non-conformities identified during the internal and external audits Compliance with ISO and other relevant standards Staff Performance and Development Staff retention and turnover rates Training hours per employee and completion of required training program Operational Improvement Implementation of process improvements and their impacts on efficiency and quality Reduction in testing cycle times and operational costs Bachelor's degree in Biological Sciences, Chemistry, or related field; advanced degree preferred.
Minimum of 4-5 years of experience in a QC laboratory, with at least 3 years in a supervisory role.
Extensive knowledge of ISO 17025 standards and quality management systems.
Experience in the field of assisted reproductive technology (ART) and familiarity with related media and devices.
In-depth understanding of analytical equipment and methods, equipment qualification and analytical method validation is required.
Experience with pH, osmolality, ELISA, Viscosity, Density, RP-HPLC, endotoxin testing, and sterility testing is an advantage.
Strong leadership, organizational, and problem-solving skills.
Excellent communication and interpersonal abilities.
Fluent in Spanish.
Strong written and oral communication skills in English as most reports and presentations will be in English.
Proficiency in laboratory information management systems (LIMS) and standard office software.
Experience with Six Sigma Green Belt and solid understanding of Lean Principles, CAPA, and DMAIC problem solving process is desired.
Passing of background check which may include verification of prior employment, criminal conviction, history, educational and driving records.
CooperSurgical does not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, genetic characteristic, or other characteristics protected by law.
Company policy also prohibits harassment of employees or applicants based on these characteristics.
