Quality Superintendent

hace 2 semanas

Ciudad Juarez, México Integer A tiempo completo

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Position scope
- Manage and direct other Quality Engineers that report directly to this position as part of the Quality Engineering staff.
- Oversee and have direct responsibility for all product transfer activities under the product transfer program in order to assure a successful implementation and product launch.
- Manage and direct process qualification and assure the validity of the validation strategy.
- Oversee and direct the development of test methodologies as required by product design qualification.
- Establish and validate inspection methodologies and product analysis as part of the process validation and routine process/product monitoring.
- In the absence of the Quality Manager he/she can act as the Management Representative, Responsible Engineer Manager designated by the Director of Operations.

Essential duties and responsibilities
- Ensure that all product transfers are completed successfully to ensure a smooth transition.
- Develop the appropriate checks and tests strategies to assure an efficacious product and process.
- Develop validation protocols utilizing a strategy that assures product quality and process effectiveness.
- Develop the appropriate matrices as leading indicators of process and product quality.
- Direct all the activities of other Quality Engineers within the same realm of product transfers.

**Qualifications**:

- Bachelor's Degree
- Bilingual English/Spanish
- +3 years of experience in similar position
- Must have excellent analytical skills and the ability to understand complex situations.
- Must have great interpersonal skills and negotiation skills.
- Must have experience in the real of Quality discipline, Medical Device manufacturing, and QSR’s.
- Must have a good understanding of ISO standard requirements.
- General knowledge of Good Manufacturing practices and FDA/QSR; ISO 13485; CMDR; MDD medical device Directive regulations, MHLW ordinance 169

U.S. Applicants: EOE/AA Disability/Veteran

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