What are the responsibilities and job description for the Supplier Quality Engineer position at Monteris Medical?
SUPPLIER QUALITY ENGINEER II/SR. SUPPLIER QUALITY ENGINEER - depending on qualifications
Purpose and Scope
Develops, establishes and maintains quality engineering methodologies, practice and processes for ensuring the quality of supplied products and meet applicable regulatory requirements. Serves as the lead Quality contact for suppliers regarding component quality and supplier qualification activities.
Ensures that product and component specifications are of sufficient detail and quality to support consistent delivery by suppliers. Also partners to create aligned receiving and inspection procedures, data trending and feedback to support the supplied product program.
Primary Responsibilities
Own quality of supplied products and components
· Investigate and inspect discrepant product from suppliers
· Identify and implement potential improvements or enhancement to supplied product quality processes in the company.
· Conduct supplier qualifications and supplier audits, with focus on ensuring ability to meet Monteris business needs
· Manage SCAR process & handle internal CAPAs related to supplied products
· Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
· Partner with Supply Chain, Manufacturing and R&D to manage vendors in an aligned manner and ensure our product specifications support outsourced production and suppliers have the capability to consistently meet those specifications
· Create appropriate R&I processes based on risk and supplier performance. Train and educate R&I inspectors on critical inspection activities
· Develop and execute validation of inspection methods utilized in R&I processes.
· Create and publish appropriate metrics on suppliers and supplied products
· Support the supplier onboarding process through the qualification of new suppliers and components
Personal Qualifications and Experience for Engineer II
Education/Experience
· Bachelor’s degree and 1-5 years quality experience
· Understanding and working knowledge of US and International regulations and standards including 21 CFR 820, MDD, and ISO 13485.
· Previous experience working within a medical device quality system
· Strong internal & external communication skills.
Personal Qualifications and Experience for Senior Engineer
Education/Experience
· Bachelor’s degree and 5 years quality experience
· Understanding and working knowledge of US and International regulations and standards including 21 CFR 820, MDD, and ISO 13485.
· Previous experience working within a medical device quality system
· Strong internal & external communication skills.
· Supplier quality, component quality, or component design experience
· Experience creating risk based supplier control plans and inspection processes preferred
