JOB DESCRIPTION
Top 3 technical skills that you are required for the role:
Validation (IQ, OQ, PQ)
Corrective Action / Preventive Action (CAPA)
Support of manufacturing process
Education Required: Bachelors Degree in Engineering or technical field
Years Experience Required: 0-3
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite (North Haven, CT)
What is your timeline for scheduling interviews? ASAP
What product line will this person support? Advanced Surgical Instruments
This position will support the Advanced Surgical Instruments Manufacturing business within ***s Surgical Innovations group located in North Haven, CT. This role is responsible for ensuring all aspects of the manufacturing process produce products to the highest possible reliability and quality. Some responsibilities include investigating and evaluating nonconforming devices and process identified during the manufacturing process as well as determining and implementing robust corrective actions to address the issues. Additionally, this role is responsible for identifying and validating improvements to reduce cycle time and improve overall production cell reliability. Monitoring and evaluation of complaints on devices used during surgical procedures is also required.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
On site support of daily manufacturing operations including troubleshooting of equipment, investigation of defects, and validation of equipment/processes.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Must Have: Minimum Requirements
Bachelors degree required
0 years of experience required
Nice to Have
Experience working in a fast paced Manufacturing environment
Validation Experience (IQ, OQ, TMV, PQ)
CAPA (Corrective Action / Preventive Action) Experience
Familiarity with Minitab Statistical Software
Six Sigma Training
About ***
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Physical Job Requirements
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