Quality Engineer III
Reports To: Senior Quality Engineer
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Provide work direction for 3-5 Technicians/Inspectors.
- Adheres to Viant 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.
- Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
- Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
- Leads and implements various product and process improvement methodologies.
- Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
- Leads in the completion and maintenance of risk analysis.
- Leads 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.
- Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
- Effectively communicate and interact with customers.
- Leads and manage complaint investigations.
- Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
- Assists with product transfers.
- Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, leads each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
- Coordinates and leads the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions
- Provides support to other quality engineers.
The successful candidate will:
- Manage a heavy workload while maintaining accuracy
- Identify potential roadblocks and provide innovative solutions
- Operate with a high level of integrity and professionalism
- Committed to and accountable for achieving goals and objectives
EDUCATION / CERTIFICATION
- Bachelor’s Degree in Engineering or related field required or 7-10 years of experience working in a quality engineering role within a regulated industry.
- 5-7 years’ experience in medical device or regulated manufacturing
SKILLS / COMPETENCIES
- Competence in the selection and use of Quality Engineering Tools and Techniques.
- Strong communication skills and ability to align with key stakeholders
- Strong working knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. FDA 21CRF820, ISO 13485:2016; MDSAP; ISO14971, QSR, MDD, TGA etc.)
- Proficient in Microsoft Office and Minitab
- Less than 10%
- Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects.
- Close vision.
- Worker is not exposed to adverse environmental conditions
At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.