Engineer II – Quality PMS

This is a fully remote position, open to applicants in California.

📋 Description

• Utilizes expertise in technical principles and BD systems/procedures to enhance manufacturing and quality processes.

• Develops project plans to guarantee that deliverables meet customer expectations, employing project management tools (such as Project Plan and Risk Analysis).

• Proficient in using the MS Office Suite, including MS Project; CAD experience is preferred (if applicable).

• Basic comprehension of statistical methods.

• Strong grasp of principles, theories, and concepts pertinent to Quality Engineering.

• Excellent problem-solving, organizational, analytical, and critical thinking abilities.

• Thorough understanding of processes and equipment relevant to assigned tasks.

• Familiarity with applicable FDA regulations in the medical device sector.

• Meticulous attention to detail.

• Capacity to interact professionally across all levels of the organization.

• Ability to juggle competing priorities in a dynamic environment.

• Must thrive in a team setting, including managing vendors and project stakeholders.

• Capability to foster productive working relationships both internally and externally.

• Comply with all company regulations and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and implement adequate measures to prevent injuries to self and others, as well as protect the environment and prevent pollution within their scope of influence/control.

⛳️ Requirements

• Bachelor’s degree in Engineering, Computer Science, Health Science, or a related scientific field.

• 2 years of experience required, or a Master’s Degree or equivalent with internship, senior projects, or thesis in Engineering or a scientific field, including relevant industry or education experience.

• Proficiency in extracting, filtering, validating, and downloading data from Power BI.

• Expertise in manipulating and analyzing large datasets using advanced Excel functions and formulas (e.g., VLOOKUP, pivot tables, conditional formulas).

• Proficient in ETQ Quality Management System.

• Experience in post-market surveillance, including review and investigation of complaints.

• Background in regulatory compliance and quality systems: CAPA, FMEA, RMW.

• Experience with quality and compliance data.

• Familiarity with Trackwise QMS is a plus.

• Strong documentation, communication (both written and verbal), and interpersonal relationship skills.

• Ability to analyze and resolve moderately complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations).

🏝️ Benefits

• Total Rewards program.

• Health insurance.

• 401(k) matching.