Benefits:

Competitive salary

Health insurance

Paid time off

Training & development

Quality Engineer II

Medica USA is looking for a motivated Quality Engineer II. The ideal candidate will have the ability to understand electrical and mechanical design principles to identify the root cause of issues. This position will identify failure modes, will write and implement SOPs and process improvements based upon the failure analysis, report on failure trends, and collaborate to identify design and/or manufacturing solutions to resolve quality issues. This role works with suppliers in an up-front, preventative mode. They will collaborate with suppliers and relevant internal departments such as purchasing. This position will be flexible, performing the responsibilities of a QT when needed, supporting complaint handling, and QE functions.

Responsibilities:

Supports the development of SOPs, documents, forms, and procedures of the quality system at medica USA as needed

Conducts and/or facilitates investigations through root cause analysis methodologies and identifies countermeasures as needed for manufacturing process, suppliers, and complaints management

Intakes, conducts and/or facilitates investigations through complaint management; MDR and/or adverse event reports and complaint trending analysis

Develops, performs and executes inspections of raw materials, finished goods, and components at medica USA; when applicable, validates test methods and/or inspection methods

Nonconformance management; conducts NCMR investigations and NCMR dispositions as result of manufacturing and/or receiving of raw materials, components, semi-finished goods and/or Finished Goods

Develop SOPs and maintain processes for documenting product requirements, specifications, verifications, and validations as needed

Supports and helps develop pfMEA; conducts risk analysis where applicable, maintains risk management files

Support and works cross functionally, specifically, supports engineering and guides engineering as well as operations in accordance with 21 CFR regulations/ISO 13485

Conducts, supports, and facilitates training in accordance with 21 CFR regulations

Supports engineering functions as needed, such as calibration management and/or validations at the discretion of the quality manager

Resolution and support of supplier quality issues and supplier management

Promotes Total Costs and Lean Manufacturing principles, with a focus on creating value and eliminating waste whenever possible

Additional quality activities as needed

Qualifications:

A Bachelor’s degree in Engineering – BSME, BSIE, BSTech (BSEE preferred) or a BA/BS degree in any other discipline with a Master’s degree in Engineering, Quality or other related discipline.

3-5+ years experience in quality engineering, supplier quality engineering and/or quality management

· Ability to apply critical thinking and creativity to problem solving

· Experience with root cause analysis; investigations and countermeasures

· Micro controls/analysis experience preferred but not required

· 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 CFR 21 regulations and ISO 13485 preferred

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