The Supplier Quality Engineer will provide technical leadership with regards to supplier quality throughout the product realization process. The supplier quality engineer provides a key role to ensure product meets defined quality standards and worldwide quality/ regulatory requirements. This position will assist in supplier quality management system improvements and defining supplier quality system processes.
- Lead the supplier selection, approval, classification, and development through a combination of audits and product or process qualifications.
- Act as liaison between Delphinus Medical Technologies and suppliers.
- Collaborate with suppliers in defining supplied material specifications, identifying critical component features and supplier manufacturing processes, developing and validating supplier manufacturing processes, and implementing appropriate process controls and monitoring.
- Assist suppliers with the development and implementation of statistical sampling plans and inspection procedures.
- Monitor, review, and report on supplier performance, in-house and to the supplier. Initiate corrective actions, as needed.
- Participate in sourcing efforts.
- Leads and participates in problem solving activities and failure investigations related to design, manufacture, inspection, and testing – including CAPA, NCRs, customer complaints, and supplier related issues to implementation and final verification of effectiveness
- Serve as technical resource for process improvement projects such as alternative measurement/testing methodologies, supplier supplied data, and Master Lot qualification programs.
- Assist in resolving internal and external audit findings and observations in Receiving Inspection.
- Develop and implement corrective actions.
- Serve as a Subject Matter Expert on the Material Review Board to determine the appropriate disposition and required corrective action of discrepant material.
- Ensure regulatory compliance in production processes with FDA QSR and ISO 13485 regulatory requirements.
- Leads and participates in IQ/OQ/PQ activities, test sample size selection, test method validations, GR&R studies and risk management activities to assure conformance to product quality standards and applicable regulations.
- Develops and manages programs that monitor, predict, or regulate research and development, manufacturing and inspection activities with the supplier.
- Supporting the management review process, by providing data such as CAPA, NCR, Risk Reviews, in-process inspection, internal and external audits, and customer feedback activities.
- Approve acceptance and measurement activities performed internally.
- Quality system support and thorough understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards and requirements.
- Provides information to demonstrate credibility and compliance with applicable regulations.
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.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formula, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
Bachelor’s and/ or Master’s degree in Engineering or Science discipline. A degree in Biomedical or Mechanical Engineering preferred and ASQ certified Quality Auditor and/or Engineer is a plus.
- Minimum 3-7 years in the medical device industry.
- Demonstrated knowledge of FDA quality system regulations and ISO 13485, FMEAs, DOE, CAPA, Risk Management, Failure Investigations, Process Validations, etc.
- Knowledge of engineering drafting programs useful (e.g. solid works or pro engineer)
- Experience with Quality Assurance/ Regulatory Compliance, principles, and systems
- Experience in the use of a product life cycle management system.
To perform this job successfully, an individual should have experience in the use of MS Office (Word, Excel, and PowerPoint), Adobe Acrobat, and document control systems.
Knowledge, Skills and Other Abilities:
- Strong interpersonal and communication skills are required as this position will entail direct engagement and management of external contractors, project team, vendors, and compliance agencies
- Strong written, verbal, analytical, and interpersonal skills
- Ability to work in fast paced environment with minimal direction or supervision provided
- Ability to work as a team as well as individually
- Strong time management and organization skills
- Ability to work effectively in a multi-disciplinary environment
- Outstanding problem-solving skills
- Ability to present ideas and results effectively
- Ability to interpret FDA, ISO regulations and prepare systems to meet those requirements
- Thorough knowledge of statistical analysis, reliability, maintainability, and risk management, include key terms and definitions, modeling, system design, assessment tools and reporting
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, use hands, and talk or hear. The employee is frequently required to stand, walk, and reach with hands and arms. The employee is occasionally required to climb or balance, and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 10 pounds. They also occasionally move objects weighing up to 20 lbs., and sometimes, but rarely, up to 50 lbs. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to see color.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles, and risk of electrical shock.
The noise level in the work environment is usually mild to moderate.
Minimal, as neededApply