Senior R&D Engineer, Med Device Quality & Compliance

Enhanced Compliance Inc.; Arden Hills (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Enhanced Compliance Inc. is seeking a senior Quality engineer to provide quality and regulatory input across design, development and validation of electromechanical medical devices.

You will ensure FDA 21 CFR 820 and ISO 13485 compliance, develop quality plans, SOPs and inspection procedures, and support CAPA and NC/NCs. You will lead design reviews, V&V activities, and apply statistical methods such as SPC, DOE and GR&R to improve product quality.

Qualifications

• Minimum 5-6 years of direct R&D experience in the medical device industry.
• Experience with durable medical capital equipment and single-use devices preferred.
• Strong written and verbal communication and technical writing skills.
• Knowledge of FDA Quality Systems Regulations and ISO standards.
• Ability to lead quality initiatives and participate in design and phase reviews.
• Familiarity with SPC, DOE, GR&R, FMEA, CAPA and process validation.

Responsibilities

• Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling).
• Develop quality documentation such as quality plans, standard operating procedures, and inspection procedures. Ensure regulatory, FDA, and ISO compliance in all areas of responsibilities.
• Represent Quality initiatives and compliance when participating and Design and Phase reviews
• Serve as an effective leader and team member in supporting quality disciplines, decisions, and practices.
• Ensure that required standards for products are documented in the product requirements (PR) specification and ensure compliance by performing quarterly gap analysis and reviewing applicable verification documentation.
• Ensure the use of statistically valid sampling techniques and teach others on the use of these and other advanced statistical techniques such as DOE and ANOVA evaluations.
• Provide direction and lead the implementation of Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans, product/component testing, inspections, and acceptance criteria.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Provide support for CAPA/NCRs/Complaints
• Assists with special projects as needed.

Skills

Communication skills

Team collaboration

Problem solving

Quality engineering

Education

Bachelor's degree or equivalent in a relevant field

Tools

DOE

ANOVA

GR&R

FMEA

CAPA

Process validation

Job description

Enhanced Compliance Inc. is seeking a senior Quality engineer to provide quality and regulatory input across design, development and validation of electromechanical medical devices.

You will ensure FDA 21 CFR 820 and ISO 13485 compliance, develop quality plans, SOPs and inspection procedures, and support CAPA and NC/NCs. You will lead design reviews, V&V activities, and apply statistical methods such as SPC, DOE and GR&R to improve product quality.