Senior Supplier Quality Engineer
The Senior Supplier Quality Engineer will be responsible for supporting the planning, management, and execution of supplier audits, qualifications, and ratings. They will lead quality coordination with suppliers and internal departments and provide guidance on regulations and problem resolution. The Senior Supplier Quality Engineer will also be responsible for activities such as supplier relationship management and supplier continuous improvement activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
- Act as a quality assurance representative on cross-functional product development, supply chain, and production teams.
- Lead supplier audits of validations, processes, controls, and quality systems to ensure compliance to regulations, quality standards, and other agreements.
- Track and qualify or disqualify suppliers according to organization’s standards.
- Maintain successful relationships with supply chain, engineering, manufacturing, and regulatory departments.
- Report supplier performance and quality to management.
- Lead the development and implementation of supplier management programs.
- Consistently follow program status, participates in cross functional decision making, and ensures team decisions are consistent with regulatory and quality system requirements.
- Proactively provide input, guidance, and/or oversight as needed on development of specifications, project plans as it pertains to supplier selection and development.
- Act as a primary quality approver of supplier quality deliverables such as score cards, audits, etc., ensuring documentation meets regulatory requirements and project target dates.
- Coordinate input and standardization of all Supplier Quality Assurance Product Development Project support and representation.
- Escalate quality issues and concerns as appropriate to quality and engineering management.
- Manage the supplier audit, review schedule, and supplier scorecards.
- Lead cross functional teams in defect resolution, track progress of resolution, and re-verify/validation defect corrections.
- Execute improvements based on technical knowledge and experience to improve the supplier process and ensure compliance with appropriate regulatory agency supplier requirements, company standards, and current industry practices.
- Provide Supplier Quality Engineering expertise in the areas of Supplier Auditing, Rating, and non-conformance resolution.
- Lead a team in the execution of failure mode analysis of processes/product, statistical analysis, and continuous improvement of supplier relationships and supplied components.
- Drive the resolution of product issues in the field, through coordination of investigations by submitting and/or initiating SCARs.
- Review critical analyses of data, independently interpret and develop conclusions, and perform reviews of protocols and reports.
- Organize data and preparing appropriate documentation for supplier selection and development.
- Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
- 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
A Bachelor’s Degree in Engineering or Scientific discipline is required and six or more years of experience in the pharmaceutical/medical device industry and a minimum of five years experience in supplier quality assurance; or equivalent combination of education and experience.
Proficient knowledge of Microsoft Office software programs, including Outlook, Word, and Excel.
- Excellent communication skills, verbal and written
- Ability to work in a team environment, as well as independently
- Ability to handle multiple tasks simultaneously
- Ability to work in a fast-paced environment
- Adaptable to change in the work environment
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.