By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers' success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Position scope/summary

Quality assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. The Sr. Engineer will be expected to provide support to Operations, interact with customers and provide support for Engineering, Quality Systems and Process engineering.

Essential duties and responsibilities

• Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards.

• Actively participates in internal audits, management review and other activities covered under Quality Manual, Policies and Procedures.

• Provide customer related quality and regulatory inquiries support.

• Compiles and writes training material and conducts training sessions on quality control activities.

• Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner. Directs development and maintenance of internal/external standards relative to Design and Development,

• Lead implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, DOE and process validation.

• Lead and provide Project Management support as needed.

• Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.

• Devices sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.

• Performs measurement system analyses to evaluate test and inspection equipment.

• Leads disposition of discrepant material and devises process to assess product quality and reliability.

• Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration. •

• Lead supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier's methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA.

• Direct support for FDA and ISO inspections and registration.

Qualifications

• 5-7 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility.

• Bachelor's degree in engineering

• Experience with FDA and ISO 13485 Certification inspections is a plus.

• Must be adept in use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred).

• Quality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include, but are not limited to Statistics, SPC, Geometric Dimensioning/Tolerancing; Sampling, Design of Experiments, etc. Ability to analyze, understand and effectively communicate this technical material. Experience with Lean Manufacturing and Six Sigma is a plus.

• Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision.

• Must possess excellent verbal & written communication skills, which include but are not limited to presentation, organizational and management skills.

U.S. Applicants: EOE/AA Disability/Veteran