- Determine if a Health Hazard Evaluation (HHE) is required.
- Coordinate the collection of data for the HHE and collaborate with the Risk Management designee as needed.
- If recall is determined as required, work within procedure and regulatory requirements to coordinate recall activities with the cross functional team.
- Draft customer recall notification letters with input from cross-functional teams.
- Draft and submit regulatory recall reports to competent authorities.
- Manage, collect, and process customer recall acknowledgement responses.
- Manage product return by customers and collaborate with warehouse staff regarding returns, count, and disposition.
- Support recall activities including, but not limited to answering customer inquiries, issue RMAs to customers.
- Draft and submit recall termination requests.
- Bachelor's degree in engineering or health related field.
- 3-5 years of experience in a Medical Device Quality Assurance/Regulatory environment
- At least one year working experience in Recall/Field Actions
- 2+ years' experience in Risk Management a plus.
- Experience working in regulated environments or knowledge of regulatory requirements, such as FDA Quality System Regulations, 21 CFR Part 806, and EU MDR 2017/745, and international standards, such as ISO 13485, ISO 14971, and IEC 62304.
- Meeting internal KPIs.
- Experience leading and performing activities, including driving successful countermeasures.
- Demonstrate collaborative patient and customer focus mindset.
- Strong verbal and written communication skills.
- Strong team player.
- Excellent organizational skills.
- Demonstrate professional approach when working with internal and external customers.
- Advanced Microsoft Office (Outlook, Word, Excel, etc.).
- Advanced knowledge of global regulatory requirements for recall activities including, but not limited to 21 CFR Part 805, 806, Health Canada GUI-0054, EU MDR 2017/745, Therapeutic Goods of Australia ARGMD, etc.
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QA System Specialist - Trumbull, United States - The Cooper Companies
Description
About CooperSurgicalCooperSurgical 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 atYou will manage and execute HHE and recall activities within regulated timelines and requirements.
You will lead through collaboration with cross functional team members, coordinate the collection of required information and data, and if required communicate field actions to competent authorities.
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 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.#J-18808-Ljbffr
