Supplier Quality Engineer
Description
- Determines methods of evaluation and inspection on supplier deliverables. Creates, maintains, and revises standard operating procedures (SOPs) associated with supplier deliverables.
- Partners with manufacturers and suppliers to provide guidance on quality assurance standards, including addressing quality issues, bottlenecks, and recommendations on improvement.
- Determines and generates an approved supplier list, continuously updating the list to ensure accuracy.
- Implements and ensures comprehensive measurement systems are in place to monitor effectiveness of supplier quality and reliability systems to identify, correct, and prevent defects.
- Determines supplier performance metrics. Assesses supplier performance for management review.
- Oversees supplier non-conformances, ensuring they are initiated, dispositioned, approved, and investigated according to procedures, plans, and applicable regulatory requirements.
- Determines and escalates supplier quality issues, ensuring appropriate actions are established to resolve issues in a compliant manner.
- Establishes requirements for annual supplier audit program, ensuring audit complies with good manufacturing practices, international organization for standardization, and any other applicable standards.
- Ensures outsourced process and product validations are performed and documented according to established procedures and timelines.
- Reviews Supplier Change Request compliance according to procedures and regulatory requirements.
- Establishes and ensures Supplier Quality Agreements are executed and up to date.
- Provides cross-functional teams with technical expertise related to supplier and quality related standards.
- Provides quality engineering support to ensure supplier compliance with FDA CFR part 820, ISO 13485, and other regulations/standards, including supplier audits, assessments, inspection technique support, verification /validation activities, Supplier Corrective Action Request (SCAR), Corrective and Preventive Action (CAPA), and change management.
- Leads the SCAR process, including process initiation, follow-up, and resolution.
- Conducts/supports onsite, offsite and virtual internal/supplier audits, if required.
- Participates in and supports audits and inspections by customers and regulatory agencies and compiles corrective and preventative responses.
- Supports internal audits, quality projects, and process improvement initiatives.
- Supports supplier nonconformance activities, such as coordinating with quality assurance and receiving inspection teams.
- Performs other related duties and projects as business needs require at direction of management.
- Bachelor’s degree in Science or related field, or any equivalent education and/or experience from which comparable knowledge, skills and abilities have been demonstrated/achieved.
- Master’s or other advanced education degree preferred.
- Minimum five (5) years of experience in supplier quality engineering or quality engineering.
- Previous experience performing GMP (Good Manufacturing Practice) and ISO (International Organization for Standardization) audits required.
- Previous experience in root cause analysis and corrective and preventive action methods required.
- Previous experience in project management, required.
- Proficient knowledge of FDA 21CFR 820 Regulations required.
- Proficient knowledge of ISO 13485 Standard required.
- Proficient knowledge of ISO 14971 Standard required.
Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell!
In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!
Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected]. Please indicate the specifics of the assistance needed.
Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.