Senior Quality Engineer - MedTech Equipment & Validation

North American Science Associates, Inc.; Irvine (CA); On-site; USD 105,000 - 115,000; Full time

Job summary

Applicants should hold a bachelor’s degree in engineering or related science with 5–7 years of relevant experience, and demonstrate strong communication, organization, and teamwork, with ability to work independently and within a team. Salary is competitive, with a market-aligned compensation range.

Qualifications

• Bachelor degree in engineering or related scientific discipline.
• 5 to 7 years of related work experience.
• Microsoft Word and Excel experience.
• Knowledge of regulatory requirements, specifications, qualifications and protocols, SOPs, and validation reports.

Responsibilities

• Manage equipment procurement process and assist in developing criteria for procurement/installation of M&TE for laboratories.
• Design and execute qualifications, requalifications and process validations of M&TE per Biotech/Pharma regulations (e.g., 21 CFR Part 820, ISO 17025).
• Analyze qualification and validation data and generate final reports.
• Ensure electronic data handling complies with 21 CFR Part 11, in coordination with IT.
• Investigate and troubleshoot using engineering methods and data analysis.
• Prepare and maintain technical documents (protocols, reports, SOPs, EOPs).
• Write and implement change control plans and risk assessments.
• Coordinate maintenance of equipment and provide training on equipment use.

Skills

Regulatory knowledge

Word & Excel

Communication skills

Time management

Team & independence

Education

Bachelor degree in engineering or related scientific discipline

Job description

Applicants should hold a bachelor’s degree in engineering or related science with 5–7 years of relevant experience, and demonstrate strong communication, organization, and teamwork, with ability to work independently and within a team. Salary is competitive, with a market-aligned compensation range.