Senior Quality Engineer, NPI Programs

Jobtailor; Acton (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Jobtailor seeks a Quality Assurance professional to drive medical device quality in a FDA-regulated setting in Acton, MA. You will lead new product introduction deliverables, risk management, and design control execution.

You will collaborate with engineering and manufacturing to implement QSR820, ISO 13485, ISO 14971, and apply statistical methods while mentoring staff to resolve quality issues.

Qualifications

• BS degree in engineering or a technical/scientific discipline, with 5+ years of experience.
• 5-7 years’ experience in FDA regulated environment.
• Experience in Quality in an FDA regulated industry.
• Experience with QSR Part 820, ISO 13485 and ISO 14971.
• ETO sterilization methods preferred.
• Experience with methods and standards for design, verification, validation of medical device products.
• Experience with statistical methods (SPC, sampling, Gauge R&R, DOE).

Responsibilities

• Ensures new product introduction quality deliverables are created and properly executed (e.g., Project Quality Plan and Risk Management Plan).
• Works with teams to establish measurable, valid product requirements.
• Supports Risk Management activities from concept through commercialization.
• Supports DHF content completion, integrity, and regulatory/standards compliance.
• Review and approve design control documentation ensuring compliance with the Insulet Quality System, QSR 820, ISO 13485 and ISO 14971.
• Provide guidance to assure country-specific compliance for distribution.
• Supports manufacturing process development & qualification for new product commercialization and product changes.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Apply sound, systematic problem solving to identify, prioritize, communicate and resolve quality issues.

Skills

Quality Assurance

FDA Regulated Environment

QSR 820 Compliance

ISO 13485 Knowledge

Total Quality Management

Problem Solving

Risk Management

Design Control

DHF Content

Statistical Methods

Education

BS degree in engineering or scientific discipline

Tools

Project Quality Plan

Risk Management Plan

Design Control Documentation

DHF Content Completion

Statistical Process Control

Sampling Plans

Gauge R&R

Design of Experiments

Job description

• Ensures new product introduction quality deliverables are created and properly executed (e.g. Project Quality Plan and Risk Management Plan).
• Works with teams to establish measurable, valid product requirements.
• Supports Risk Management activities from product Concept through Commercialization.
• Supports DHF content completion, integrity, and regulatory and standards compliance.
• Review and approve design control documentation (e.g. plans, protocols, reports) ensuring compliance with the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971.
• Provide guidance as needed to assure country specific compliance to the laws and regulations of the targeted market for distribution.
• Supports manufacturing process development & qualification for new product commercialization and product changes.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues.

Requirements

• BS degree in engineering, a technical or scientific discipline and 5+ years' experience; or equivalent combination of education and experience.
• 5-7 years’ experience in the FDA regulated environment.
• Experience in Quality in an FDA regulated industry.
• Experience with QSR Part 820, ISO 13485 and ISO 14971.
• Experience with ETO sterilization methods preferred.
• Experience with methods and standards for the design, verification, and validation of medical device products.
• Experience with statistical methods (e.g. statistical process control, sampling plans, gauge R&R, and design of experiments).

Core Competencies

Demonstrates expertise in Quality Assurance within FDA regulated environments, focusing on compliance with QSR Part 820, ISO 13485, and ISO 14971. Proficient in risk management, project direction, and systematic problem-solving methodologies for medical device product development.

Highest-signal resume keywords

• Quality Assurance
• FDA Regulated Environment Experience
• QSR Part 820 Compliance
• ISO 13485 Knowledge
• Statistical Methods

ATS Optimization Keywords

Hard Skills

• Project Quality Plan
• Risk Management Plan
• Design Control Documentation
• DHF Content Completion
• Statistical Process Control
• Sampling Plans
• Gauge R&R
• Design of Experiments
• Verification and Validation
• ETO Sterilization Methods

Soft Skills

• Coaching
• Mentoring
• Problem Solving
• Communication
• Team Collaboration

Industry Keywords

• Medical Device
• Regulatory Compliance
• Quality System Regulation
• Risk Management
• Manufacturing Process Development