Senior Quality Engineer
Reports To: Quality Manager
Viant Medical is currently looking for a dynamic Senior Quality Engineer. The Sr. Quality Engineer will be responsible for identifying and driving the resolution of internal and external quality issues. Activities include: ownership of CAPAs; direct interaction with Operations, Customer Operations, and Engineering on technical issues and solutions; direct technical support of product development projects; initiation of and support for process validations; support of customer, registrar, and other external audits; performing internal audits; and systemic improvements to the overall Quality Management System.
- 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 and quality system requirements and assuring complete and correct Device History Records are maintained.
- Reviews the adequacy and correctness of changes to Bills of Material (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
- Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent recurrence.
- Reviews quality data for potential CAPA’s, including analyses of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analyses.
- Assists with product transfers.
- Works with suppliers, management, engineers and manufacturing associates in the resolution of quality problems through capability studies and the application of statistical quality control, including Cpk, DOE, Hypothesis Testing, etc.
The successful candidate will have a winning attitude, strong interpersonal skills, and demonstrated success in living the “continuous improvement” philosophy and driving change within cross-functional teams. Ability to work independently with minimal direction. Ability to effectively communicate in both written and verbal form. Ability to manage time and priorities effectively to ensure on-time completion of tasks.
Minimum Education: BS in Engineering or similar discipline, preferably Mechanical Engineering.
- 7+ years of Quality Assurance experience, preferably in a medical device manufacturing environment or other regulated industry.
- Experience with root cause analysis, DOE, statistics, lean manufacturing, trending, Risk Management, and Six Sigma methodologies. Proficient in Microsoft Office and Minitab. Familiarity with metals processing and the Toyota production business model helpful, but not required.
- Candidates should be able to work in a fast paced environment, and have the ability to make quick and confident decisions to achieve results.
- Good interpersonal skills are needed to be able to communicate and engage with the workforce in a positive manner.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; and vibration. The noise level in the work environment is usually moderate.
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.