What are the responsibilities and job description for the Sr. Quality Engineer position at OBP Medical?
About CooperSurgical
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 www.coopersurgical.com.
Summary
The Sr. Quality Engineer is a key member of the Quality Control group providing technical project execution and leadership, support new product development, and engage in continuous improvement activities for a variety of activities within the stem cell operations group. Under the supervision of the Manager – Quality Control and Hematology, the Sr. Quality Engineer’s role is to support the development and implementation of new equipment, processes, materials, and test methods through designing and executing critical qualification and validation activities. As an individual contributor, the incumbent will be expected to develop and maintain procedures and protocols for both studies and qualifications, support Quality Control activities with regards to product testing, contribute to calibration and maintenance activities, and report on QC KPIs.
Essential Functions & Accountabilities
Qualifications
Knowledge, Skills and Abilities:
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
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 www.coopersurgical.com.
Summary
The Sr. Quality Engineer is a key member of the Quality Control group providing technical project execution and leadership, support new product development, and engage in continuous improvement activities for a variety of activities within the stem cell operations group. Under the supervision of the Manager – Quality Control and Hematology, the Sr. Quality Engineer’s role is to support the development and implementation of new equipment, processes, materials, and test methods through designing and executing critical qualification and validation activities. As an individual contributor, the incumbent will be expected to develop and maintain procedures and protocols for both studies and qualifications, support Quality Control activities with regards to product testing, contribute to calibration and maintenance activities, and report on QC KPIs.
Essential Functions & Accountabilities
- Responsible for equipment, process, and test method validations for CBR, as assigned. This includes writing and executing protocols, as assigned.
- Responsible for supporting creation of material specifications and quality release requirements for critical supplies.
- Support development and implementation of processes to support new product development and technical transfer activities.
- Define, develop and manage various quality projects and validation studies to ensure compliance with global regulatory requirements.
- Provide technical training and guidance to team members assigned to specific process and project activities
- Provide technical guidance and execution resources for cell culture activities associated with HCT/p production.
- Execute quality control testing of client specimens and raw materials.
- Demonstrates knowledge of FDA guidance documents for manufacturing activities and requirements as outlined in 21 CFR 1271 (cGTPs). Familiar with AABB Cell Therapy accreditation standards.
- Contributes to risk assessment activities
- Perform other duties and projects as required.
Qualifications
Knowledge, Skills and Abilities:
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Ability to speak and write English; communicate effectively and professionally with clients and external contacts; read and interpret documents such as procedure manuals; write reports and business correspondence; respond to common inquiries or complaints from clients and regulatory agencies; and effectively present information and respond to questions from management.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals and to compute rate, ratio, and percentage. Ability to identify and utilize appropriate statistical methods and apply those appropriately to experimental or process related data.
- Ability to analyze data; interpret a variety of instructions furnished in written or oral form; and solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- This role works mostly in climate-controlled environments in both an office and laboratory setting. Will be required to properly wear personal protective equipment appropriate for each working environment.
- As a part of daily activities, this role will work with products stored at cryogenic temperatures as low as -198°C
- As a part of daily activities, this role may come in contact with bloodborne pathogens or infectious substances, toxic or dangerous chemicals, and liquid nitrogen.
- Required to lift and or move up to 54lbs by themselves
- Previous experience in handling, processing, culturing, and testing cord blood, cord tissue, and placental tissue.
- Experience in experimental design, validation design and execution, and new product development activities.
- Familiar with operating within a Quality Management System.
- Previous experience participating in and leading technical projects.
- Familiar with basic and intermediate life science laboratory techniques.
- Previous experience working within certified clean room environments.
- Training in the handling of liquid nitrogen and associated storage equipment.
- Bachelor’s degree in life science related discipline and a minimum of five years of related experience; experience with software systems, project management, and quality systems.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
- Job Identification 7606
- Job Category Engineering
- Posting Date 04/24/2025, 01:07 AM
- Job Schedule Full time
- Job Shift Day
- Locations 6550 S. Bay Colony Dr, Tucson, AZ, 85756, US (On-site)
- Company CooperSurgical
