LIM Innovations

Quality/Regulatory Engineer

The LIM QR Engineer is responsible for the Quality function at LIM.  As a key technical member of the Operations team, the QR Engineer is critical in the effort to ensure delivery of safe, reliable and cost effective products needed to improve the mobility and quality of life of our users.

Major responsibilities:

• Collaborate with Product and Production Engineering Teams in the development of robust quality system and reliability test plans in support of FDA regulated medical device design, development and manufacturing.

• Establish and execute quality control and reliability plans for all product including test plans, reliability testing, inspection plans, work instructions, test equipment acquisition and supplier quality.

• Identify, apply, and update engineering and technical standards requirements for devices, including standards compliance in product design, manufacture, and labeling.

• Trend, analyze, and report on Quality metrics. Investigate and resolve out-of-control metrics.

• Lead and/or execute process improvement projects as needed.

• Participate as Quality representative on cross-functional teams

• Partner with in-house manufacturing team and external suppliers to develop and maintain quality practices,  standards and deliverables.

• Support CAPA process by performing root cause analysis, implementing corrective action and performing effectiveness verification.

• Ensure that compliance to ISO 13485 and 21 CFR 820 requirements is maintained

• Evaluate and approve product changes (ECO) and monitor design developments for maintaining quality compliance.

• Facilitate continuous improvement initiatives across all functions

• Lead all internal and external quality and notified body audits events at both the state and federal level.

Qualifications:

• BS in Engineering or related field

• 3+ years experience in medical device field.

• Working knowledge of appropriate industry standards and statistical analysis/software strongly desired

Skills and Abilities:

• Strong collaboration and presentation skills with a demonstrated ability to influence and negotiate in a cross functional environment

• Attention to detail and strong follow-up tendencies

• Effective team leadership ability

• Highly developed communication skills adapted to a fast paced, growth oriented environment

• Strong data analysis skills with experience in the application statistical methods to design reliability and process capability.

• Ability to multitask, be hands on, dive deep as needed, perform under pressure and meet deadlines

• Willingness to wear many hats in a growth oriented organization

• Working knowledge of six-sigma, lean and other continuous improvement tools and methodologies

• Proficiency in Microsoft Word and Excel.