Job Description:

Essential Duties, Responsibilities and Qualifications may include the following.  (Other duties may be assigned.)

 

1. 
   New Product Development:
   
   
   
   • Develop, document, and execute new product verification testing for products within and outside of existing product lines.
   
   
   • Review and audit new product development activities and documentation to meet quality system requirements.
   
   
   • Able to make decisions on complex technical matters related to areas such as inspection and testing.
   
   
   
   

 

2. Process Improvement and Manufacturing Support:

• Able to identify, coordinate, and execute manufacturing and business process improvement projects.


• Review new technology equipment and process qualifications including IQ/OQ/PQ. 


• Evaluate and determine product disposition for non-conforming product.

 

3. Quality Assurance:  

• Investigate, determine, and document root cause and corrective action for quality related issues such as corrective actions and non-conforming product.


• Review and audit product structures, drawings, specifications and procedures for completeness and application to CIVCO ISO 13485 quality system.


• Investigate, determine, and respond to customer complaints including OEM complaints


• Execute internal audits of CIVCO business unit quality system.


• Plan, execute and report on external supplier audits

 

4. Personal Development:

• Attends all relevant training and actively pursues further training/education.


• Keeps abreast of relevant developments in technology.


• Utilize statistical techniques and programs to make quality decisions.

 

 

5. Leadership and Supervision

• Able to provide mentoring and coaching within Quality department and broader organization.


• Able to supervise and manage quality engineering internship program (as applicable).

 

Other Skills and Abilities: 

• Demonstrates documentation, process management, root cause investigation, quality analysis tool, and troubleshooting/problem solving skills.


• Demonstrates interpersonal and self-management skills.


• Experience with Microsoft Office and statistical analysis programs such as Minitab.


• Experience with manufacturing processes such as heat sealing, injection molding, machining, and assembly.


• Prefer experience in a regulated environment such as ISO 13485.


• Prefer internal auditor certification in a regulated environment.


• Regular attendance is required for the ability complete work.


• Requires face-to-face interaction with team members, peers and management to complete work and provide support.

 

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed above are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Education and/or Experience

Minimum of a Bachelor's degree (BS) in engineering from a four year college or university; and three to five years related experience and/or training or equivalent combination of education and experience.

 

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

While performing the duties of this job, the employee is regularly required to sit; reach with hands and arms and talk or hear.  The employee is frequently required to use hands to finger, handle, or feel.  The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.

 

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts.  The employee is occasionally exposed to toxic or caustic chemicals and risk of electrical shock.  The noise level in the work environment is usually moderate.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Engineering

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