Quality Engineer

Quality Engineer

REPORTS TO Vice President

Function: Quality, Safety, Risk Management

Job description

Join Our Dynamic Team: Quality Engineer

**Location**

Westchester County, NY

**Company**

An emerging startup at the forefront of patient centric wound care and compression.

**About Us**

We are an innovative startup devoted to improving patient care with at home wound care and compression solutions. Our commitment is to bring accessibility of best-in-class care with products that can be self-applied at home, bridging the gap with technology for patients and physicians.

**The Role**

We’re on the lookout for a vibrant Quality Engineer to be the creative energy behind our brand!

**Key Responsibilities**

· Assists in regulatory and quality aspects of planning and developing of R&D projects.

· Help the organization in compliance with National, international Quality, Regulatory requirements.

· Provide individuals within the organization, with Regulatory information and referral on technical matters as required

· Work requires, Operational, Regulatory and Administrative experience.

· Update all quality Manuals, SOPs, and follow all ISO document procedures

· Review all field complaints and develop corrective action plans

· Assist the VP in overall product quality by conducting Root Cause analysis and preparing the Risk Reduction strategies

SPECIFIC RESPONSIBILITIES

· Helps the organization in compliance with National, international Quality, Regulatory requirements.

· Assists the organization in the quality and Regulatory aspects of execution in company

development projects.

· Assists in Development of new policies and procedures and revise existing policy and procedures.

· Follows all ISO document procedures and facilitate training as required.

· Initiates communication with Patents on resolving product complaints.

KNOWLEDGE, SKILLS AND ABILITIES

· Knowledge of Medical device Regulatory Requirements, manufacturing, QMS Systems and Audit preparedness and Audits.

· Two years of Risk Management and Risk Reduction strategies. Ability to think conceptually and analyze operation data impacting company resources.

· Willingness to learn quickly and disseminate knowledge to R&D, engineering and manufacturing.

QUALIFICATIONS

· BS Degree in Engineering.

· Master of Science, and international experience is a plus.

· 2 years of experience in Risk Management managing product development of sterile and non- sterile medical devices.

· Experience in documenting, analyzing and resolving patient complaints on timely manner.

WORKPLACE CONDITIONS

· The employee frequently is required to sit and use a computer keyboard, mouse, telephone.

· The employee is occasionally required to stand and reach with hands and arms.

· Specific vision abilities required by this job include close vision and viewing a computer screen.

Training Requirement

Given the multi-disciplinary nature of the position, a working knowledge of all company policies is required. Training will follow the Training Chart, involving all company SOP’s, QM and ISO and FDA regulations.

**Requirements**

A flair for creativity and an eye for detail.

Strong communication skills and a team-player / can do attitude.

Thrives in very tight timelines and rapid turnaround environments.

**Perks**

Be a pivotal member of a budding startup.

An environment that champions growth and innovation.

Join us as we stride ahead in the realm of wound care and compression.

Interested? Drop your resume and portfolio at HR@sun-scientific.com.

Work Location: In person

Job Type: Full-time

Pay: $65,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• Paid time off

Schedule:

• 8 hour shift

Work Location: In person