Quality Engineer

Viant • Brimfield, MA

5d

About The Position

The Quality Engineer provides Quality Engineering support for Operations to ensure that Quality System requirements are followed in medical device manufacturing and operations in accordance with applicable regulatory and standards requirements. The role works with manufacturing, engineering, quality, supply chain, suppliers, management, customers, and manufacturing associates to maintain product quality, support compliance, and resolve quality issues. It may provide work direction for 3–5 Inspectors/Technicians and support other Quality Engineers. Travel is less than 10%.

Requirements

• Bachelor’s degree in Engineering or a related field, or 2–5 years of experience working in a quality engineering role within a regulated industry.
• 2–5 years of experience in medical device or regulated manufacturing.
• Competence in selecting and using Quality Engineering tools and techniques.
• Strong communication skills and ability to align with key stakeholders.
• Strong working knowledge of interpreting and applying relevant domestic and international regulations and industry standards, including FDA 21 CFR 820, ISO 13485:2016, MDSAP, ISO 14971, QSR, MDD, and TGA.
• Proficiency in Microsoft Office and Minitab.
• Ability to manage a heavy workload while maintaining accuracy.
• Ability to identify potential roadblocks and provide innovative solutions.
• High level of integrity and professionalism.
• Commitment and accountability for achieving goals and objectives.

Responsibilities

• Adhere to Viant Core Beliefs and safety and quality requirements, including QMS, EMS, FDA regulations, company policies and procedures, and other regulatory requirements.
• Support regulatory and agency inspections, audits, investigations, and inquiries regarding product design and manufacturing quality.
• Monitor manufacturing of assigned products for compliance with DMR, provide deviation and waiver guidance, and ensure Device History Records are complete and correct.
• Lead and implement product and process improvement methodologies.
• Review changes to Bills of Materials, assembly procedures, drawings, component specifications, FMEAs, and control plans for adequacy and correctness.
• Lead the completion and maintenance of risk analyses.
• Lead the generation and completion of test method validation protocols and reports.
• Work with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies; recommend process monitoring devices where applicable.
• Develop inspection techniques and procedures to ensure products meet design specifications, and write, approve, and implement incoming, in-process, and final inspection procedures.
• Ensure nonconforming material dispositions meet regulatory requirements and corrective actions are adequate to prevent recurrence.
• Communicate and interact effectively with customers.
• Lead and manage complaint investigations.
• Lead plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes.
• Assist with product transfers.
• Work with suppliers, management, Engineers, and Manufacturing associates to resolve quality problems; lead capability studies and application of statistical quality control methods, including Cpk, DOE, and hypothesis testing.
• Coordinate and lead preparation of Quality Plans, including inspection, test, and gauge requirements for new product introductions.
• Provide work direction for 3–5 Inspectors/Technicians when applicable and support other Quality Engineers.
• Perform other functions as required.

Benefits

• Full medical, dental, and vision coverage effective on the first day of employment.
• 401(k) effective on the first day of employment.
• Generous paid time off.
• 10 paid holidays.
• Growth opportunities.
• On-demand pay access to earned wages.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level