Quality Engineer
Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
POSITION SUMMARY:
The Quality Engineer (QE) will be responsible for management and of assigned quality projects in order to meet quality assurance objectives. This position will work cross functionally to support and enhance quality processes ensuring compliance with regulatory requirements quality standards and internal procedures.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Creates and updates quality system procedures working on crossfunctional teams to align best practices procedures and applicable regulations (FDA ISO etc.
- Evaluates product changes and directs appropriate disposition of product through the companys change control system
- Responsible for creation of inspection models inspection prints gaging or other inspection documents and detailed testing requirements to insure receipt of quality product
- Support concurrent engineering efforts by participating in design development projects representing quality assurance and the customer (supplier and end user)
- Responsible for creating and maintaining product and process risk management files to meet FDA and ISO standards
- Reviews product and documentation nonconformances and recommends inspection product and/or quality system modifications
- Interfaces with supplier quality representatives concerning issues with quality assurance and assures that effective corrective action is implemented
- Supports product transfer activities to current and new suppliers
- Participate in hands on cadaver labs
- Participates in projects and supports actions initiated in the Continuous Improvement program
- Participates in project Kaizens Rapid Improvement Events and build a Continuous Improvement and Lean culture across the organization
Qualifications :
EDUCATION & EXPERIENCE REQUIREMENTS:
- Bachelors degree in Engineering Science Technology or a related field required.
- 3 years of progressive medical device engineering experience (Manufacturing Development or Quality Engineering) within an FDAcompliant Title 21 section 820 environment
- Preferred experience with virtual surgical planning or custom medical devices
- Ability to travel 1030 of the time for vendor visits audits process troubleshooting etc.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Treaces Privacy Policy
It is Treaces policy not to discriminate against any applicant for employment or any employee because of age color sex disability national origin race religion veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer
Treace is a drug free employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
