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