About the job...
As one of the key members of the Quality group, you will, with general supervision, own and lead
projects from solicitation and proposal through design transfer. You will be responsible for assuring products conform to established requirements and standards through appropriate audit,
inspection, validation and test activities. Directly supports the company, and interacts with many different functional departments, customers, suppliers, and internal and external experts to implement Quality goals.
Responsibilities:
- Contributes to the design and development of complex new products with an emphasis around ensuring design control (ISO 13485) and risk mitigation (ISO 14971) standards are met in line with company policies and procedures.
- Formulates procedures, specifications, and standards for products and processes.
- Participates in Team Meetings under Project Leader with cross-functional team.
- Determination and validation of inspection methods.
- Supports manufacturing and manufacturing engineering in the validation of suppliers and processes.
- Development of work instructions, device master records, test and inspection methods and visual standards.
- Reviews and approval of documents created within team.
- Identifies critical personnel, gauges, procedures, and materials needed for the qualification of new products.
- Creates production reports, manages supplier assessment and approved supplier lists (ASL) & creates audit plans.
- Manages the nonconformance process (customer, internal, supplier) which includes trend analysis, corrective and preventive actions for assigned products or product families.
- Ensures that suppliers have necessary information and facilities to deliver quality products meeting specifications.
- Manages quality aspects of projects, as required (timelines, prototypes, testing, suppliers, etc.).
- Contributes to cross-functional project teams to support all quality deliverables for design and development.
- Drives problem solving of product quality design and process related issues from product development through release and including quality-related product sustaining activities.
- Communicates and works with manufacturing to ensure design manufacturability and proper Risk Assessment.
- Meets with and works closely with the project manager and customer to ensure all requirements are defined and met.
Qualifications:
- Requires a bachelor’s degree in engineering in Mechanical or Biomedical Engineering or equivalent work experience.
- A minimum of 4 years’ experience in product quality within the medical device industry is preferred.
- Previous knowledge and experience in manufacturing processes of chemicals & plastics is preferred.
- Computer skills including Microsoft Office and Manufacturing Management products.
- Must be familiar with cGMP requirements.
- Recommended to have experience with EPA, FDA regulations (i.e. 21 CFR 820, ISO 13485: 2016 & 21 CFR 211).
