Sr. Quality Tech - 1st Shift
  • Job Posting Expires: 8/10/2024
8M ago
$0 to $0
Full Time
No
Manufacturing
2-4 Years
None
Primary Duties

Responsibilities

  • Follows standard operating procedures to test molds, component parts and finished products for errors, documenting outcomes and ensuring effective production processes and remediation of any errors.  Rejects non-conforming product and disposition rejections

  • Investigates and verifies quality of products associated with customer complaints (reviews data, inspects complaint and sample provided by customer, conducts testing) – compiles responses to customers detailing investigation results, and provides final investigation reports to Quality Engineers and Quality Manager

  • Monitors customer complaints for potential adverse incidents

  • Monitors mold equipment to verify proper maintenance is being applied and conducts particulate and viable testing to ensure production occurs in a clean and sterile environment.

  • Administers Kappa testing with process inspectors to ensure defects can be detected consistently.

  • Coordinates with internal stakeholders to communicate and resolve matters pertaining to medical device production.

  • Releases accepted finished product to Sterilization in a timely manner

  • Trains production team on quality issues as needed

  • Files and controls archived device history records

  • Collects weekly lab samples for silicone and volume testing

  • Reviews and revises inspection procedures and other controlled documents.  Distributes controlled forms and procedures and ensures obsolete items are removed

  • Performs process and documentation audits

  • Complies with statutory responsibility under the national/federal regulations - take reasonable care of your own health, safety and welfare along with teammates that may be affected by your acts at work

  • Follows established EH&S procedures and policies and encourage teammates to follow them

  • Participates in EH&S activities such as: root cause analysis, finding solutions, implementing improvements, inspections, and meetings

  • Completes and remains up to date on required EH&S training

  • Follows all ISO 13485, GMP, OSHA and plant/corporate standards, policies, and procedures

  • Reports all safety incidents, hazards, and potential unsafe working conditions

  • Works overtime as required

  • Other duties as assigned with or without accommodation


Required Knowledge, Skills, and Abilities

Qualifications

  • 2-4 years of experience in related field, preferred

  • Previous manufacturing experience preferred

  • High School diploma, GED or equivalent, or equivalent work experience, preferred

  • Understanding of FDA regulations surrounding the manufacturing of medical devices preferred

  • Experience with Six Sigma and Lean Manufacturing tools would be an asset

  • Proficiency with MS Office preferred


Compensation Details

Anticipated hourly range: $18.40 per hour - $26.30 per hour

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

  • Medical, dental and vision coverage

  • Paid time off plan

  • Health savings account (HSA)

  • 401k savings plan

  • Access to wages before pay day with myFlexPay

  • Flexible spending accounts (FSAs)

  • Short- and long-term disability coverage

  • Work-Life resources

  • Paid parental leave

  • Healthy lifestyle programs

 

Application window anticipated to close: 08/9/2024 *If interested in opportunity, please submit application as soon as possible.

 

The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.


Benefits

See above.