Senior Supplier Quality Engineer
Senior Supplier Quality Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Position Summary: ***** This position is remote in Michigan. Candidate will need to travel to Auburn Hills regularly.****** The Senior Supplier Quality Engineer will maintain quality assurance standards which adhere to Quality System Requirements (21 CFR 820) ISO regulations (ISO 13485) and other applicable regulations to ensure products and services are provided to customer requirements. This position is responsible for the quality and regulatory compliance of products manufactured at Suppliers and External Manufacturers.
Duties and Responsibilities: Under limited supervision and in accordance with all applicable government laws regulations and ASP policies procedures and guidelines this position:
Will monitor quality performance of suppliers and external manufacturers implement inspection and test methods for assigned product lines manufactured at suppliers where required participate in Technical assessments & quality system audits of suppliers to identify potential areas of risks process variability and address root causes.
Will perform process variability studies Risk analysis test method variability and establish sampling plans using valid statistical techniques
Lead in the investigation of complex manufacturing product quality and compliance issues with assistance from appropriate SMEs (e.g. CAPA nonconformances audit observations) for all production processes based on engineering principles; analyze results make recommendations and develop action plans. Will lead or support teams to investigate quality issues (Failure investigations) to resolve complaints nonconforming products and CAPA
Will provide support to develop and maintain good documentation to support the Validation Process specifications manufacturing and test procedures. Support and/or approve the preparation of validation and qualification protocols and support the execution of process / product qualifications &validations (IQ OQ PQ) projects with suppliers and external manufacturers.
Will participate and collaborate with Supply chain R&D Engineering Operations Engineering and Manufacturing to identify potential areas of process variability address root causes and implement improvements. Supports in the identification and ensure the optimization of complex Manufacturing processes using engineering methods
Will participate in preparation of Process/Design Failure Mode and Effects Analysis ( PFMEA / DFMEA)
Will participate in new product development team activities in the development and qualification of suppliers
Responsible for communicating business related issues or opportunities to next management level
Performs other duties assigned as needed
Candidate will be required to travel globally for Supplier assessments Quality Business Reviews and compliance audits.
Qualifications
Education: High School or Equivalent Associates Degree Bachelors Degree Masters Degree PhD Degree Electrical Engineering (BSEE) Mechanical Engineering (BSME) Chemical Engineering (BSCE) BS Microbiology (BSc) or other related Engineering practices is required.
Years of Related Experience: 35 years of work experience (or equivalent) in the Medical Device industry medical field or regulated environment or in other applicable quality roles.
Knowledge Skills Abilities Certifications/Licenses and Affiliations: (Include any required computer skills regulatory knowledge certifications licenses languages cognitive and behavioral abilities etc.)
Prior experience within an electromechanical or chemical environment as well as previous medical device experience is preferred.
Prior knowledge of medical device regulations such as 21 CFR 820 and ISO 13485 are preferred.
Experience with process validations and the use/application of statistical tools is preferred.
Must be able to work in a team environment including frequent interorganizational and outside customer contacts. Candidates who have prior experience in (sampling design of experiments process capability analysis) as well as the capability to review manufacturing processes (Control plan process control and quality control) will be given higher considerations
This position will have interactions with cross functional teams including but not limited to Supply chain R&D Engineering Operations Engineering Manufacturing Sourcing other Quality departments and Regulatory
This position may have interactions with Government agencies third party registrars and Customers.
This position will also be interacting with Components and External Suppliers.
Physical & Work Environment Requirements Physical Requirements: The physical demands identified are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of this job. While performing the responsibilities of this job the employee may be required to talk and hear. The employee is often required to sit and use their hands and fingers to handle or feel. The employee is occasionally required to stand walk reach with arms and hands climb or balance and to stoop and kneel. Vision abilities required by this job include close vision.
Travel on the Job: Up to 30% Domestic International
Required Experience:
Senior IC
Employment Type
Full-Time
