Engineer II (Quality) (Local Candidates Only)

Draper - Draper Quality

16 Jan 2022

Draper - Draper

Quality

Quality Assurance

Full Time

3

3 years

We are looking for local (currently living in Draper or the surrounding SLC area) candidates to the Draper Area. We are not considering non local candidates and there is no relocation package offered.

Duties: Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Please refer to the job description for additional details.

Key Responsibilities:

• Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.

• Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk • Develop, update, and maintain technical content of risk management files • Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes • Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.

This person will be responsible to support the day to day operation of the Multipack lines and some of the specific tasks associated to that role are the following

Support the final disposition of returns Support the final disposition of damaged products and components Day to day issues at the DC/ warehouse Support Supplemental Labeling operation Support the Multipack Lines (kitting) Monthly trending/ metrics NCR/ CAPA/ SCAR initiation, investigation and processing

This role will require travel to a distribution center located in Kentucky, up to 25%.

Skills: • Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills • Basic understanding of statistical techniques • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering • Solid problem-solving, organizational, analytical and critical thinking skills • Solid understanding of processes and equipment used in assigned work • Knowledge of and adherence to Quality systems • Experience with FDA Quality System Requirements (QSR), ISO 13485 • Strict attention to detail • Ability to interact professionally with all organizational levels • Ability to manage competing priorities in a fast paced environment • Must be able to work in a team environment, including the ability to manage vendors and project stakeholders • Ability to build productive internal/external working relationships • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Keywords:

Education: Education and Experience: Bachelor's Degree in Engineering or Scientific field, 2 years of related work experience Required or Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education Required Minimum of 1 year Experience in Medical Device Industry, Engineering, Operations Quality, Quality Systems, or equivalent Skills and Experience: