Job description

Technical Documentation Specialist

About CooperSurgical:

CooperSurgical is a leader in manufacturing and marketing multiple trusted and innovative brands that assist clinicians in improving the health of women, babies and families worldwide. Through an aggressive growth and diversification strategy, CooperSurgical has evolved its portfolio of over 600 products to include products and services used primarily by obstetricians and gynecologists in surgical and medical procedures wherever they occur: in hospitals, surgical centers, medical offices and fertility clinics.

Work location: Trumbull, CT (contract role only for 8-12 months)

Position Summary:

The Technical Documentation Specialist supports the Project Engineering Department of Operations in completing minor specification and process changes and supporting project engineers in documenting major changes per QMS requirements.

You will aid the department Manager in managing change control projects. This includes drafting documentation required for internal Engineering Change Control (ECN) projects, New Part Entries (NPE), Discontinuation Processes, Root Cause analyses, and process procedure documentation updates.

You Will:

• Produce all documentation required for change control processes outlined by CSI QMS. Prepare or attach standardized risk review documentation.
• Process all NPE documentation, following up throughout approval process to ensure on time delivery.
• Build product and part discontinuation process, completing all documentation and routing requirements.
• Aid in the preparation, formatting, updating, and routing of all Controlled Level I, II and III documents and forms in Master Control to include: SOPs, Work Instructions, Labeling [including DFUs], controlled forms, and other documentation identified for storage in Master Control.
• Maintain hard copies of all approved documentation, and maintain electronic document databases for important projects.
• Maintain compliance with ISO, FDA QSR and other related quality standards for Document and Change Control.
• Support approval of product labeling and documentation.
• Perform additional responsibilities by management.

You Have:

• Bachelor's Degree in technical area of study.
• Experience working with Quality Management System tools and continuous improvement methodologies.
• Experience in electronic document management, including process flow.
• Experience with MS Office Suite, with advanced skills in Microsoft Excel required: V-lookups, pivot tables and graphs.
• Experience with Master Control Documentation.
• Technical background in Engineering concepts, drawings/blueprints, and medical Devices.

Our Benefits:

As an employee of CooperSurgical, you'll 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 www.coopersurgical.com 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.

Job Type: Contract

Pay: $28.00 - $36.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Trumbull, CT 06611: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

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