Job description

Quality Technician (Validation)

Summary:
The Validation Technician will perform a wide variety of engineering and performance tests to validate new designs, product improvements and process changes. The
Validation Technician will conduct robust testing in accordance with documented test plans, protocols, and applicable standards to determine whether test specimens meet the effectiveness, durability, and safety criteria specified in the test plan. This technician will ultimately support in the protocol development process.

Essential Duties & Responsibilities

• Assist in the preparation of validations, protocols and reports (including IQ, OQ, PQ)
• Set up and run development and validation testing
• Document results from testing and prepare data/information for/in validation reports
• Support technical root cause and resolution of issues found during testing
• Select and install instrumentation needed to collect data
• Utilize standard test equipment such as calipers, micrometers, comparator, etc. with no direction.
• Support design and repair of simple mechanical fixtures, jigs, and harnesses.
• Monitor equipment calibrations and work with vendors to ensure calibrations are conducted.

Secondary Duties & Responsibilities

• Participate in the investigation process pertaining to customer complaints, CAPAs, or internal investigations and customer communication.
• Read and interpret specifications, Process Flow Diagrams, Potential Failure Mode and Effects Analysis and Process Control Plans.
• Provide input on inspection methods related to continuous improvement initiatives related to the job.
• Assist in the development, implementation, and review of quality processes, measures, and procedures.
• Understand and comply with the company’s quality management system (ISO

13485).

• Understand and comply with the company’s safety policies and procedures.
• Perform additional duties to comply with departmental objectives, as required.

Qualifications

• Minimum Associates degree required or equivalent work experience
• 2-5 years of experience with validation testing
• Experience using various test methods
• Ability to read schematics/drawings and use manufacturers’ product data sheets
• High level of interpersonal and communication skills
• Ability to work in a fast-paced environment with minimal supervision
• Willing to work flexible hours and passionate about getting jobs done.
• Ability to coordinate outside testing
• Hands-on approach: Proactively identifies and fills in gaps where needed
• Ability to travel for work related experiences
• Injection Molding experience (desired)
• Thorough knowledge of Microsoft Office
• Ability to read and write English, bilingual (Spanish) a plus
• Attention to detail, organization, and strong multitasking abilities
• Experience with root cause analysis/8D
• Excellent decision making and time management skills
• Commitment to continuous improvement

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and follow work instructions and job training requirements. The individual must be able to stand for a full manufacturing shift and have ability to complete hand assembly process. The individual must have the ability to reach with arms extended and/or overhead, excellent hand dexterity, ability to bend, stoop, stretch and similar activities and ability to lift up to 35 pounds frequently.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

This job description should not be construed to contain every function/responsibility that may be required to be performed by an incumbent in this position. Incumbents are required to perform other related functions as assigned.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Relocation assistance
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: One location

www.colinoncars.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.colinoncars.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, www.colinoncars.com is the ideal place to find your next job.