Quality Specialist

Westfall Technik is a global holding company which provides innovative plastics manufacturing solutions to the healthcare, consumer package goods and light industrial vertical markets. The site locations, operating within the Westfall Technik enterprise, are internationally aligned with unmatched global reach in the industry. Our proprietary Stacked Integration Model enables us to operate leveraging a high degree of specialization, extensive capacities in end-to-end design, production and assembly, and first-class references in high-end manufacturing.

ONE WESTFALL

Competitive advantages such as vertical integration, speed-to-market and advanced manufacturing systems allow us to streamline our processes and be a complete solution provider positively impacting our customers' business. We are powered by experienced people with diversified capabilities and specialties. We pride ourselves in developing customized solutions with precision and care. So, while there is complexity to what we do; we simplify the process to deliver a customer experience that is enjoyable and easy; providing a single point of accountability.

ALL IN.

This simple phrase captures what Westfall Technik is all about. The statement embodies the company's commitment to total support, complete manufacturing capabilities and its bold approach. It is our internal rallying cry. It is our philosophy. Nothing half-hearted.

Associates (and Customers) can be confident that this mantra drives the organization to be nimble, scalable and comprehensive ----no matter how complex the customers' challenge.

We look forward to having an interesting conversation with you.

JOB DESCRIPTION

Title: Quality Specialist

Position: Full Time, Non-Exempt

Location: Union City, Ca

Manager: No

Reports to: Quality Manager

SUMMARY OF ROLE

The Quality Specialist is responsible for assisting in all aspects of quality and inspection at Westfall Technik including product inspections, report creation and procedure development.

DUTIES AND RESPONSIBILITIES

* Responsible of Document Control. Review, create and coordinate document changes

* Responsible for creating and updating inspection templates

* Assist Customers with regulatory documentation like REACH, RoHS statements

* Create and distribute final inspection reports per Customer requirements

* Create internal quality documents related to QMS, quality alerts, PVPs etc

* Assist on peer trainings for example on new procedures, procedure changes, new work instructions etc.

* Assist on the MRB activities

* Support coordinating the calibration program as required

* Support Quality analysis of all product run/shipped (zero defects to customers).

* Support with documentation/information retrieval during audits

* Support the inspection group as necessary

* Ensure overall customer satisfaction through quality assessment and prompt responsiveness to inquiries

* Utilize machinery & prioritize equipment usage to obtain the quickest lead times

* Maintain an attitude of continuous improvement by making and implementing suggestions for improvements

* Maintain a department that is neat, organized, and clean at all times

MINIMUM REQUIREMENTS AND QUALIFICATIONS

* High School degree minimum, advanced degree a plus

* Experience on writing procedures, work instructions and inspection plans

* Ability to understand the requirements of ISO 13485:2016 and CFR 820 preferred

* A working understanding of Excel and Word are required

* Blueprint reading is a must

* Position requires strong organizational abilities and mechanical aptitude

* Strong ability to write professionally in English, Bilingual in Spanish is a plus

* Must work in a team environment to accomplish all tasks of the department and be able to communicate effectively both written and verbally

* Requires the ability to operate inspection equipment, from hand gages to automated machines

ESSENTIAL FUNCTIONS AND 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 stand, walk, sit, use hand to finger, or feel, reach with hands and arms, and talk or hear

* The employee must occasionally lift up to 25 lbs when necessary

WORK ENVIRONMENT

The work environment is usually in an office within a manufacturing facility with low to moderate noise level. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

PAY RANGE: DOE - $55,000 - $62,000

Westfall -Technik is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex, gender, gender identity, gender expression, pregnancy, childbirth or related medical conditions, religious creed, physical disability, mental disability, age for individuals age 40 and over, medical condition (as defined by state law (for example, cancer or genetic characteristics or HIV/AIDS), marital status, military and veteran status, sexual orientation, genetic information, citizenship status or any other characteristic protected by federal, state or local law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment