Quality Engineer

Viant • Brimfield, MA

6d • $70,000 - $95,000 • Onsite

About The Position

The Quality Engineer provides Quality Engineering support for Operations to ensure Quality System requirements are followed in medical device manufacturing in accordance with applicable regulatory and standards requirements. The role supports product and process quality, regulatory compliance, audits, investigations, product improvements, validations, inspection activities, and corrective and preventive action. It works closely with customers, suppliers, Manufacturing, Engineering, management, and other associates, and may provide work direction to 3–5 Inspectors/Technicians.

The successful candidate can manage a heavy workload accurately, identify potential roadblocks and develop innovative solutions, act with integrity and professionalism, and remain accountable for achieving goals and objectives. The role requires a bachelor’s degree in Engineering or a related field, or 2–5 years of experience in a quality engineering role within a regulated industry, along with 2–5 years of experience in medical device or regulated manufacturing. 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, such as 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

• Follow Viant Core Beliefs and applicable safety, quality, environmental, regulatory, company-policy, and operating-procedure requirements, including QMS, EMS, and FDA regulations.
• Support regulatory and agency inspections, audits, investigations, and inquiries concerning product design and manufacturing quality.
• Monitor manufacturing of assigned products for compliance with DMR; provide deviation and waiver guidance and ensure complete, accurate Device History Records.
• 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 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, coordinate process validations and capability studies, and recommend process monitoring devices where applicable.
• Develop inspection techniques and procedures to ensure products meet design specifications; write, approve, and implement incoming, in-process, and final inspection procedures.
• Ensure nonconforming material dispositions meet regulatory requirements and that 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-cause analysis.
• 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, 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 as needed.
• Support other Quality Engineers and perform other functions as required.

Benefits

• Full medical, dental, and vision benefits 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