Quality Systems Engineer

Job Description

Salary: $80,000-$95,000

Summary

Responsible for supporting the Quality System by evaluating procedures, processes, and developing and implementing improvements to maintain compliance with established policies and applicable regulations.

Essential Duties and Responsibilities

Must create and update Quality System SOPs and Wis.

Must develop protocols, perform and document design verification and validation activities.

Must provide support in maintaining compliance according to 21 CFR Part 820 and maintaining ISO 13485 and MDSAP certifications.

Must provide support during regulatory submissions.

Must provide support during internal/external audits.

Must perform studies to meet certain international recognized standards.

Must contribute towards design control activities.

Must coordinate with other departments to address any deficiencies.

Identify gaps in the Quality System processes and work towards remediation.

Must provide support to create and maintain DMR, DHF, and Technical File.

Design and draw product and design specifications using SolidWorks.

Must contribute towards risk analysis and management activities in compliance with ISO 14971 standard.

Must act in the role of CAPA owner when assigned and act as a CAPA coordinator by leading other departments solving problems during the CAPA process.

Must document NCMR and work towards timely closure.

Must provide support with material inspections.

Must have experience with eQMS tools, preferably Qualio.

Must participate in new product development.

Must be able to run post market surveillance reports, preferably using data analytics report software such as Power BI.

Must provide support in other areas when required.

Job Requirements

Must have a minimum of B.S. degree in Engineering or Life Science, M.S. preferred.

Must have at least 3 years of work experience in the medical device industry.

Special Skills, Abilities, and Requirements

Language Skills

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

Ability to write routine reports and correspondence.

Ability to speak effectively before groups of customers or employees of organization.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Must be able to work independently and in a team.

Must have strong sense of responsibility.

Must have strong attention to detail and analytical skills.

Computer Skills

MS Office (Word, Excel, PowerPoint, Flow-Charting) and database management.

Solid Works

Power BI

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.

The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually low to moderate.

Full-time