Sr Quality Engineer
Sr Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
About CooperSurgical
CooperSurgical is a leading fertility and womens 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 womens healthcare providers including testing and treatment options.
CooperSurgical is a whollyowned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical headquartered in Trumbull CT produces and markets a wide array of products and services for use by womens health care clinicians. More information can be found at .
Summary
TheSr. Quality Engineer is a key member of the Quality Control group providing technical project 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 Engineers 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.
Responsibilities
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 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.
Travel: As required < 10
Qualifications
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.
Work Environment:
- This role works mostly in climatecontrolled 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 198C
- 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
Experience:
- Previous experience in handling processing culturing and testing cord blood cord tissue and placental tissue.
- Experience in experimental design validation design and 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.
Education:
- Bachelors degree in life science related discipline and a minimum of five years of related experience; experience with software systems project management and quality systems.
As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us at to learn more about CooperSurgical and the benefits of becoming a member of our team.
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 viaemail 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.
Required Experience:
Senior IC
Employment Type
Full-Time
