Supplier Quality Engineer
This position will lead the improvement of existing manufacturing processes interfacing with supplier and internal engineering groups to resolve problems encountered in the supply chain and assess capability and capacity of suppliers to perform current or potential future work. Develop training materials and other resources to support improvements in supplier performance and productivity. Projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Determine Annual Supplier Audit Schedule/Plan.
2. Support supplier quality management programs such as supplier selection and certification.
3. Act as lead auditor or auditor during supplier audits.
4. Lead supplier quality development projects and continuous improvement activities.
5. Investigate/coordinate supplier quality issues resolution with the appropriate department, including the dispositioning of non-conforming product, event, deviation, and out of specification reports.
6. Initiate and follow up on Supplier Corrective Action Requests (SCARs).
7. Validate supplier corrective actions involving design and/or process changes to ensure they are robust, sustainable, and implemented for similar potential concerns across manufacturing lines and/or suppliers.
8. Identify Procurement Spec Review and Change Requests.
9. Work with Product Development and Manufacturing/Process Engineers to develop appropriate receiving inspection test methods, sampling plans and acceptance criteria for new and existing components and materials, including first article inspection.
10. Review and monitor strategic supplier performance, including providing trend analysis, investigation, and CAPA for monthly quality review.
11. Liaise with internal customers to ensure effective problem resolution, develop metrics and reports, and identify supplier non-conformance trends.
12. Develop and implement product quality plans, documents and systems by creating product and quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
13. Assist management in implementing and maintaining a quality system that adheres to European, US, Canadian and other regulatory and Quality System requirements (ISO 13485, CFR Part 211/820, Q7).
14. Assist with Regulatory Internal or Notified Body audits.
15. Perform continuous improvement activities/projects to improve Product Quality, Compliance, and the Quality System.
16. Provide leadership for New Product Introduction at Suppliers.
17. Plan, execute, and deliver projects effectively within defined time/cost parameters.
18. Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
19. Support NorthStar’s Quality System and Health & Safety Program by following policies and procedures.
Ability and willingness to travel, both domestically and internationally, up to 30 % of the time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor’s Degree in an Engineering or Scientific discipline and a minimum of three to five years pharmaceutical industry experience in the area of supplier management; or equivalent combination of education and experience. Candidate must possess solid working knowledge of applicable national and international quality system regulations and standards including 21 CFR part 210/211, 21 CFR part 820, Q7A and ISO 13485.
Proficient knowledge of Microsoft Office software programs, including Outlook, Word, and Excel, as well as database packages, project management, and other applications.
Experience with SPC and data analysis
Excellent communication skills, verbal and written
Ability to work in a team environment, as well as independently
Ability to handle multiple projects simultaneously
Ability to work in a fast-paced environment
Adaptable to change in the work environment
Certified Lead Auditor or ability to complete training in Lead Auditor certification
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line