Quality Engineer

Viant Medical Inc.; Brimfield (MA); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental & Vision insurance

401(k)

Paid time off

Holidays

On-Demand Pay

Growth opportunities

Job summary

Viant Medical Inc. is seeking a Quality Engineer to support Operations by ensuring the Quality System requirements are met for medical device manufacturing and operations.

The role emphasizes compliance with FDA regulations and ISO 13485, while contributing to continuous improvement and risk management. You will collaborate with Manufacturing, Engineering, and Quality teams, lead CAPA activities, and participate in process validations and documentation control to ensure product quality from

Qualifications

• Bachelor’s degree in engineering or related field or 2–5 years in quality engineering in regulated industry.
• Experience with FDA regulations and ISO 13485 is preferred.
• Experience in medical device manufacturing quality systems.
• Strong communication and teamwork skills.

Responsibilities

• Adheres to safety and quality requirements including QMS, EMS, FDA regulations, company policies and procedures.
• Supports regulatory inspections, audits, investigations, and inquiries regarding design and manufacturing quality.
• Monitors manufacturing for compliance with DMR and maintains Device History Records.
• Leads product and process improvement methodologies and CAPA activities.

Skills

Quality engineering

Regulatory knowledge

Communication

CAPA & root cause

Documentation & records

Education

Bachelor’s Degree in Engineering or related field

Tools

Minitab

Microsoft Office

Job description

New employees are eligible for the following benefits effective date of hire!

• Full Medical, Dental & Vision, 401(k), effective on your 1st day
• Generous paid time off benefits and 10 paid Holidays
• Growth Opportunities
• On-Demand Pay: Access your pay as soon as you have earned it!
• We offer market competitive compensation. Potential salary range for this role is $70,000-95,000 annual wage. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Description

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.

Responsibilities

• 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
• This position may provide work direction for 3-5 Inspectors/Technicians.
• Provides support to other quality engineers.
• Performs other functions as required.

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 2 – 5 years of experience working in a quality engineering role within a regulated industry.

Experience

• 2-5 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

Travel

• Less than 10%

Physical Requirements

• 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