Benefits/Perks

Competitive Compensation

Career Growth Opportunities

Job Summary Medica USA is looking for a motivated Quality Engineering Manager. This position is 100% onsite and will manage the processes and personnel to support manufacturing and identify failure modes, write and implement SOPs, conduct process improvements, report on trends, and collaborate to identify design and/or manufacturing solutions to resolve quality issues. The ideal candidate will have the ability to understand electrical and mechanical design principles to identify the root cause of issues. This role works with internal and external stakeholders in a proactive, collaborative method.

Responsibilities

Manage a team to develop SOPs and maintain processes for documenting product requirements, specifications, verifications, and validations in compliance to regulations and requirements

Collaborate with internal and external stakeholders to develop requirements for product development

Promote Total Costs and Lean Manufacturing principles, with a focus on creating value and eliminating waste.

Resolve supplier quality issues and manage supplier quality performance -- SQP management, PIQ/PPM metrics,

Outline and implement improvements to Quality System, and manufacturing processes

Work on assigned projects with limited supervision

Represent Quality for new and existing product improvement, manufacturing transfers, and quality plan initiatives. Support protocol, procedure and specification development.

Supports internal and external audits

Qualifications

A Bachelor’s in Engineering, Physical Science or similar. Masters Degree or MBA preferred. or a BA/BS degree in any other discipline with a Master’s degree in Engineering, Quality or other related discipline.

5+ years experience in quality engineering, supplier quality engineering and/or quality management

Ability to apply critical thinking and creativity to problem solving

Strong knowledge of computers, computer applications, and electronic instrumentation

Strong quality mindset, and ability to identify quality-focused continuous improvement opportunities

Passionate about improving product quality

Experience with FDA QSR is desirable

Ability to communicate both to all levels within the organization and externally to suppliers