What are the responsibilities and job description for the Quality Assurance Specialist position at CooperSurgical?
About CooperSurgical
JOB DESCRIPTION
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 .
Responsibilities
The Life Science Quality Assurance Specialist II is a mid-level quality professional responsible in maintaining, quality system processes and programs to include: Supplier Quality, Investigation Systems, Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA) management, training, and document review. In this role the candidate will work with cross functional teams aiding in root cause analysis, risk remediation and management. The candidate should have strong written and verbal communication skills to foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset.
Essential Functions & Accountabilities:
☒ Training Program – Creation and implementation of training for the Quality Event Module to help Quality customers and Business Unit Quality Event System owners
☒ Deviations and Nonconformances: Review, approve and monitor the events and deviations. Complaint handling and investigations Track and facilitate investigation in cross functional team
☒ Compliance: Audit and ensure compliance to applicable standards for Quality Events.
☒ AABB, AATB, FACT, FDA (HCT/P, cGMP, cGTP), 21CFR 1271, Health Canada and ISO regulations
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 DESCRIPTION
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 .
Responsibilities
The Life Science Quality Assurance Specialist II is a mid-level quality professional responsible in maintaining, quality system processes and programs to include: Supplier Quality, Investigation Systems, Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA) management, training, and document review. In this role the candidate will work with cross functional teams aiding in root cause analysis, risk remediation and management. The candidate should have strong written and verbal communication skills to foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset.
Essential Functions & Accountabilities:
- Provide Quality oversight and support as needed by Quality customers.
- Support and partake in Quality Management System Processes such as:
☒ Training Program – Creation and implementation of training for the Quality Event Module to help Quality customers and Business Unit Quality Event System owners
☒ Deviations and Nonconformances: Review, approve and monitor the events and deviations. Complaint handling and investigations Track and facilitate investigation in cross functional team
☒ Compliance: Audit and ensure compliance to applicable standards for Quality Events.
- Perform compliance review on executed procedures and training
- Identification of risk and risk mitigation
- Work cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records.
- Recognizes errors in records and resolves them in a timely manner.
- Perform other Quality Assurance Duties as required.
- Bachelor’s degree (BA) from four-year college or university or Associates degree (A.A.) with three to five years related experience and/or training.
- OR four to six years related experience and/or training; or equivalent combination of education and
- Candidates must show knowledge and proficiency in the Quality Assurance Specialist I role
- Candidate should demonstrate knowledge of regulations and standards such as:
☒ AABB, AATB, FACT, FDA (HCT/P, cGMP, cGTP), 21CFR 1271, Health Canada and ISO regulations
- Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.
- Familiarity or experience with the following is strongly preferred: Basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.
- Knowledge of Master Control, or similar eQMS a plus
- Demonstrated experience and proficiency in Microsoft Office applications, Word, Excel and PowerPoint.
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.
