CooperSurgical
In-Process QC Inspector (Manufacturing)
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.
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.
Position Location: Trumbull, CT
Position Summary:
This individual will be responsible for supporting the Operations Quality Assurance department adhering to FDA 21 CFR regulations, ISO 13485 and cGMP.
Essential Functions:
• Performs assigned routine inspections on materials, goods in process, or finished goods where results are compared with company quality standards.
• Perform other quality related duties as required.
• Act as resource for Geometric, Dimensioning and Tolerance (GD&T) questions and suggestions. Review inspection techniques to ensure accurate and repeatable inspections can be performed.
• Serve as a resource to other departments on quality issues. Interface and attend meetings with personnel from other departments for the purpose of information exchange, drawing and procedure change process, troubleshooting, training, and problem solving.
• Generate NCMR when inspection data exceeds acceptable limits or when major incidents of poor quality are noted.
• Performs visual, dimensional, and functional inspection, utilizing hand-tools, vision systems, and electronic equipment.
• Performs other duties or assignments as required by management.
• Has the ability to communicate job requirements for purposes of training.
• Associates with various department functions to provide corrective and preventive action plan.
• Performs tasks using good housekeeping practices and safety techniques.
• Makes recommendations for revision of department procedures as required.
• Has the ability to make recommendation on disposition of questionable products.
• Records results electronically and reports number of defects found. Maintains electronic and paper-based files for readily retrievable access of records.
• Performs detailed inspection when necessary to determine quality of product.
• Works with production, engineering and quality engineering.
• Audits product at various stages of the manufacturing process including visual and functional inspection as well as mechanical testing.
Qualifications:
• Ability to review and comprehend written instructions, including blueprints, specifications, and methods.
• Blueprint reading skills including knowledge of GD&T.
• Working knowledge of Microsoft Windows, Excel, Word, and Outlook.
• 5+ yrs. experience in quality inspection required, preferably in an FDA regulated industry.
• ASQ Certification preferred (Certified Quality Inspector or Certified Quality Technician) or relevant experience.
• Basic computer skills.
• Ability to multitask in a fast-paced environment.
• Strong communication skills.
• Must possess a high school diploma or GED
• Knowledge of GMP's, Device History Records
• Dexterity and precision required to operate gauges and testing equipment. Working knowledge of common inspection measurement, testing tools, and equipment required.
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