Provides hands on QE support for Operations to ensure the QMS requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
Essential duties and responsibilities
Adheres to Integer Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
Lead generation and completion of protocols and reports for test method validations.
Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
Ensure that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
Lead and manage complaint investigations.
Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
Participate in continuous improvement projects.
Assist with product transfers.
Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
Mentor and support quality inspectors and technicians.
Performs other functions as required.
Environmental working conditions
Normal office environment
Typically, Bachelor's degree in engineering, equivalent degree or extensive work experience Two to five years' experience in manufacturing, preferably medical devices, or other regulated industries. Must be familiar with and understand recognized regulations and standards such as (where applicable)
- 21 CFR Part 820 (FDA QSR, cGMP)
- EU - Medical Device Directive (MDD) 93/42/EEC
- ISO 9001 Quality Management Systems
- ISO 13485 - (EN) ISO 13485 Medical Devices - Quality Management Systems
- ISO 14971 Risk Management
Able to be technically comprehensive and knowledgeable including standard business ERP system principles, as well as technical aspects such as statistics, documentation, SPC, Geometric Tolerancing and mechanical drawings and associated software packages. Must possess excellent verbal & written communication skills, as well as presentation, organizational and management skills. Ability to interface with customers, problem solve and drive solutions to meet customer requirements. Strong communicator with internal and external customers in all areas of the business: written and verbal (one-on-one and group). Rational thinker: good business judgment and ethics. Entrepreneurial attitude and mindset combined with the appropriate process orientation, focus and willing to embrace change. Self-motivated with a sense of urgency and accountability. Energetic and hardworking. High level of intellectual curiosity combined with strong problem solving and analytical skills. Innovative, practical, technically astute, and capable of healthy dialogue in the exchange of ideas in reaching conclusions. Proficient in Microsoft Office and Minitab
It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to, or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.
Resolve Quality Issue
Perform Statistical Analysis
Use Statistical Tool
Use Quality Tool