What are the responsibilities and job description for the Quality Engineering Specialist 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.
CSI believes the quality, safety, and efficacy of our products are of the utmost importance to ensure we deliver impactful solutions that improve healthcare. The CAPA Coordinator will be responsible to administer Trumbull CAPA (Corrective and Preventive Action) System and ensure the timely and accurate completion of all CAPA activities. This individual will need to possess strong organizational, problem-solving, and communication skills.
Essential Functions & Accountabilities
This position may require 5% domestic and international travel.
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.
CSI believes the quality, safety, and efficacy of our products are of the utmost importance to ensure we deliver impactful solutions that improve healthcare. The CAPA Coordinator will be responsible to administer Trumbull CAPA (Corrective and Preventive Action) System and ensure the timely and accurate completion of all CAPA activities. This individual will need to possess strong organizational, problem-solving, and communication skills.
Essential Functions & Accountabilities
- Administer Trumbull site CAPA system.
- Works closely with other functional areas with the use of investigational tools to determine the root cause of any nonconformity, ensures that CAPA plans address root causes, and ensures that corrective actions and preventative actions are implemented to facilitate the rapid, compliant, introduction of new/improved products, processes, and systems.
- Responsible to ensure that actions are executed on time, thorough, complete, meet the needs of the business and customers and that required standards and/or procedural requirements are met.
- Implement necessary follow-up verification/milestone checks on Corrective and Preventive Action items, ensure timely follow-up and approval occur throughout term of the CAPA process.
- Facilitate cross-functional meetings with internal and external parties as required.
- Responsible for maintaining CAPA tracking tools/databases. Responsible for sending periodic reminder notifications to CAPA owners.
- Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
- Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
- Support external and internal audits in CAPA related topics and any other Quality System task as per Management request.
- Continuously improve CAPA system, procedure, forms and any other related Quality System document.
- Serve as CAPA trainer for new current and new CAPA owners in the CAPA process and system.
This position may require 5% domestic and international travel.
- Bachelor’s degree in a health, Engineering or Science field required.
- Minimum of 3 years of experience in medical device or healthcare industry related experience.
- Working knowledge of FDA regulations, ISO 13485, MDSAP.
- 3 years working with CAPA Investigation Systems.
- External / Internal Audit experience.
- Strong knowledge of relevant quality standards and regulations, including ISO 13485, 21 CFR 820, MDSAP
- Proven experience in CAPA investigation, Root Cause Analysis (Investigation Tools)
- Have strong written and verbal communication skills.
- Must be organized and able to prioritize duties and responsibilities.
- Must demonstrate initiative, proactiveness, innovation, and analytical problem-solving skills.
- Able to interact with all levels and disciplines of employees.
- Must have attention to detail and multi-tasking ability.
- Strong communication and interpersonal skills
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 5237
- Job Category Engineering
- Posting Date 08/19/2024, 06:29 PM
- Job Schedule Full time
- Locations 95 Corporate Drive, Trumbull, CT, 06611, US (On-site)
- Company CooperSurgical
