Quality Engineer
Company: IRP Medical, part of Integrated Polymer Solutions
Location: San Clemente
Posted on: August 7, 2022
Job Description:
About Us: The IPS portfolio of market-leading brands provides
world-class advanced materials from eight facilities across the US
and the UK. Our primary business streams include engineered
elastomers, signature materials and biomedical solutions. Led by
experienced executives, each brand serves specific needs, but all
share a culture of superior execution and customer service. We have
market-leading positions in critical and challenging market sectors
that help enable the future with innovative, safe and sustainable
solutions. We collaborate with our customers to meet the future
demands of a rapidly evolving world by providing best-in-class
solutions.
Job Overview:Responsible for the implementation, coordination and
directing of quality control and quality assurance activities
necessary to comply to relevant regulatory requirements of FDA and
ISO 13485 and customer specific requirements. As Our Sr. Process
Engineer, You Will:
- Implement, coordinate and direct quality control activities
necessary to meet customer requirements and relevant regulatory
standards in manufacturing
- Review and verify testing and inspection results and records
for receiving, in process, and final inspection to support system
compliance and product release for shipment
- Participate in and contribute to continuous improvement
programs to improve efficiency for higher yields, less waste and
enable to maintain lot acceptance by AQL sampling
- Coordinate established acceptance sampling plans and adjust to
tighten or loose AQL level based upon risk and lot performance
- Coordinate and maintain Calibration program of all measurement
and test equipment including its calibration recall, servicing, and
documentation
- Provide support and interact with customers for the
investigation of CCFs (Customer Complaint and Feedback)
- Maintain processing of CCFs, RGAs, NCRs and CAPAs through
IRPDBS system
- Host site audits performed by customers and third party such as
regulatory bodies and respond to their requests for information
about the QMS
- Maintain adherence to clean room requirements by monitoring
particle count and enforcement of GMPs and GDPs
- Follows all safety and company policies
- Other duties can and may be assigned as necessary to support
department and company needs
Qualifications:
- Must be knowledgeable in ISO 13485 quality requirements and
applications in a manufacturing environment
- Knowledgeable in Quality System Regulations FDA 21 CFR - Part
820 cGMP and good documentation practices
- Minimum of 2+ years relatable experience in quality control,
assurance and engineering within a manufacturing environment,
medical molding preferred
- Demonstrated experience with inspection and measurement
concepts, methods, techniques and procedures
- Hands on skills in using measurement and test equipment such as
handheld and vision systems
- Ability to read part drawings and interpret GD&T
characteristics and symbols
- knowledgeable in Sampling Inspection Plans such as AQL
sampling
- Hands-on leadership skills with strong organizational,
planning, and team building background
- Ability to communicate effectively, both written and verbal,
among staff and management
- High standards of personal and professional integrity
- Bachelor's degree in Science, engineering is preferred
- Proficiency in written and oral Spanish is a plus Employee
Benefits:We offer excellent benefits including medical, dental,
life insurance, long term disability, holidays, birthday bonus,
401k with matching and a bonus or customized commission plan.
Location:IRP Medical - 1035 Calle Amanecer, San Clemente, CA 92673
IPS recruits, employs, trains, compensates and promotes regardless
of race, religion, color, national origin, sex, disability, age,
veteran status, and other protected status as required by
applicable law. At IPS, we have a clear vision: to be the place
where a diverse mix of talented people want to come and do their
best work. We pride ourselves on providing best-in-class solutions
to our customers around the world; our company runs on the hard
work and dedication of our passionate and creative employees. IPS'
dedication to promoting diversity, multiculturalism, and inclusion
is clearly reflected in our organization. Diversity is more than a
commitment at IPS-it is the foundation of what we do. We are fully
focused on equality and believe deeply in diversity of race,
gender, sexual orientation, religion, ethnicity, national origin
and all the other fascinating characteristics that make us
different. We maintain a policy of non-discrimination in providing
equal employment to all qualified employees and candidates
regardless of race, sex, sexual orientation, gender identity, age,
color, religion, national origin, disability, genetic information,
protected veteran's status, or other legally protected
classification in the state or locality in which a person is
employed.
Keywords: IRP Medical, part of Integrated Polymer Solutions, San Clemente , Quality Engineer, Engineering , San Clemente, California
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