Direct Hire/Permanent Position
The Quality Engineer will own, manage and execute quality processes in accordance with local and national regulations and standards for medical devices. The role is to support new product development efforts and implement, maintain and execute the quality management system. Applies engineering practices and techniques to specific situations, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps or processes. The Quality Engineer is expected to be the company SME for design controls and combination product quality and supplier assurance.
Essential Functions / Responsibilities
The Quality Engineer implements and assists with all aspects of the company’s Quality Management System and programs with respect to global Regulatory (FDA, ISO, MDD and international Regulatory agencies) and Quality requirements for products and services. This hands-on role involves close collaboration and interaction with and active support of all departments.
- Contributes to the research, development, and authoring of technical documentation (SOPs, protocols, reports, etc.) for internal and external use in accordance with FDA/ISO requirements and guidelines.
- Creates documentation associated with engineering activities (e.g. Quality Plans, Verification and Validation Protocols/Reports)
- Analyze data (NC’s, CAPA’s) from multiple inputs to identify areas of high risk to the business and communicate those risks appropriately with management
- Investigate and determine root cause as a result of complaints, R&D activities, audit findings, nonconforming product/processes, etc. and communicate appropriately with management
- Responsible for the Calibration Program, ensuring equipment calibrations are tracked and accurately maintained in a timely manner
- Assist with the Supplier Quality Program to include maintaining Supplier Files and performing supplier audits
- Regulated medical device environment in accordance with 21 CFR 820 and ISO 13485
- Maintains Device Master Records, Device History Records and all relevant files for compliance to Quality System Requirements.
- Ensures that Standard Operating Procedures and Standard Inspection Procedures are current for all distributed products.
- Processes OEM Engineering Change Request (ECR/ECO’s) and internal Engineering Change Notices (ECN’s) or Document Change Requests (DCRs).
- Creates and submits Document Change Requests (DCR). Tracks all planned and non-planned deviations, and revises operating procedures accordingly. Create clear and unambiguous step-by-step work instructions for complex processes and ensure training is conducted.
Requirements & Qualifications
Minimum Associates Degree in technical field. Bachelor’s Degree in related technical field preferred, and 5-7 years of experience in medical device manufacturing with 3-5 years’ experience with direct supervision of a Quality System in Quality Assurance or Regulatory Affairs, writing technical documents that comply with FDA/ISO 13485 standards required; or equivalent combination of education and experience. ASQ certification a Plus.
- Experienced and knowledge of ISO13485 in manufacturing environment
- Working knowledge of FDA Quality System Requirements, all applicable medical device ISO standards, MDD and CMDCAS.
- Strong engineering principles (statistical data analysis, risk management, FMEA, reliability, validation, development and execution of protocols/reports.
- Knowledge of 510(k) submissions.
- Organized with high attention to detail.
- NC / CAPA experience according to requirements of ISO 13485 / 21 CFR 820
- Strong computer skills, with proficiency in electronic document management systems. Must have excellent verbal and written communication skills, exceptional interpersonal skills, and the ability to work cooperatively and collaboratively with others. The ability to multi-task, work with minimal supervision, and demonstrate resiliency and high productivity in a fast-paced environment is required.
- Positive, results-oriented and energetic team player
- Excellent analytical and problem-solving skills
- Excellent interpersonal and communication skills
- Ability to work independently and collaboratively
- Ability to prioritize and manage to critical project timelines in a fast-paced environment
- Ability to follow established policies and procedures and comply with regulatory requirements
- Ability to deal with unresolved situations, frequent changes, delays or unexpected events