Supplier Quality Engineer
Openwater
DEPARTMENT: Supply Chain
REPORTS TO: Vice President of Manufacturing and Supply Chain
PURPOSE
As Medical Device Supplier Quality Engineer, you ensure the quality of Openwaters’s products by managing and overseeing the quality standards of both our contract manufacturers and component suppliers. This role will play a critical part in managing supplier performance, conducting audits, implementing quality controls, and supporting new product introductions (NPI) in collaboration with internal and external stakeholders.
The quality engineer investigates current issues with product and related manufacturing processes. This includes analysis of complaints or non-conformance reports, updating technical files as well as analysis of manufacturing process related data. The ideal candidate will have a strong background in medical device quality assurance, supplier management, and manufacturing processes.
SPECIFIC DUTIES AND RESPONSIBILITIES
· Implement, and maintain quality management systems for contract manufacturers and component suppliers that are compliant to international medical device regulations.
· Perform assessments of potential suppliers against product specific international standards
· Support operations by tracking incoming inspection and materials handling metrics. Provide oversight and guidance for incoming quality requirements and processes.
· Primary ownership and trending of the Nonconforming Materials system.
· Maintain product documentation including purchased parts specifications, FMEA, and quality documentation.
· Monitor and assess supplier performance through metrics (PPM, SCARs, Non-Conformances, Supplier scorecards, etc.).
· Conduct regular audits and assessments (ISO 13485, FDA QSR, ISO 9001, etc.) at supplier facilities to evaluate production processes, quality control measures, and adherence to specifications and regulatory compliance. Provide feedback and work with suppliers to implement necessary improvements.
· Manage suppliers to close audit findings, non-conformances, and verify corrective actions.
· Drive preventive actions with suppliers to address quality issues and prevent occurrence.
· Investigate quality issues related to supplied components or manufacturing processes. Manage suppliers to resolve issues, reduce defects, and prevent recurrence through root cause analysis and corrective action plans.
· Assist in the development of new suppliers, ensuring they understand and can meet our quality expectations. Provide training and support to enhance supplier capabilities where necessary.
· Monitor the inspection process for incoming components from suppliers, ensuring they meet design specifications and quality standards before they enter the production line.
· Maintain comprehensive records of supplier performance, audit results, and quality incidents. Prepare detailed reports for management and stakeholders on supplier quality metrics and improvement initiatives.
· Ensure all suppliers adhere to contractual agreements regarding quality, delivery, and service. Negotiate quality agreements, terms and conditions when necessary.
· Work closely with internal teams including procurement, engineering, and production to align supplier quality with product development and manufacturing goals.
· Lead qualification and validation of new suppliers, processes, and components (FAI, PPAP, IQ/OQ/PQ).
· Lead initiatives for continuous improvement in supplier manufacturing and quality processes. Implement best practices.
· Stay abreast of changes in medical device regulations and standards to ensure ongoing compliance.
SUPERVISORY RESPONSIBILITIES
· None
EDUCATION
· BS degree in engineering, quality assurance, or a related field.
EXPERIENCE
· Minimum of 8 years of experience in quality engineering, with a focus on supplier quality management.
· Minimum of 5 years experience in a Medical Device production environment.
KNOWLEDGE AND TRAINING
· Proven track record in managing relationships and performance with contract manufacturers and component suppliers.
· Working knowledge of statistical process control (SPC), failure mode and effects analysis (FMEA), and problem-solving methodologies and related software tools.
· Knowledge of quality standards such as ISO 9001, AS9100, ISO 13485 or similar.
· Proficient in quality tools and methodologies (e.g., FMEA, SPC, Control Plans).
· Effective communication and collaboration skills to work with cross-functional teams.
· Attention to detail and a data-driven approach.
· Ability to communicate clearly and concisely, both orally and in writing, with the ability to present complex information clearly.
· Comfortable with domestic and international travel to suppliers, manufacturers, and product development sites.