Senior Quality Engineer

namsa; Irvine (CA); On-site; USD 105,000 - 115,000; Full time

Job summary

NAMSA is a leading provider of medical device materials and services, supporting clients through the entire development lifecycle. The role focuses on managing procurement of measurement and test equipment (M&TE) for laboratories and ensuring compliance with testing standards.

The ideal candidate has a engineering degree, 5–7 years of experience, and strong knowledge of regulatory requirements and QA documentation, with hands-on experience in qualifications, validations, and documentation

Qualifications

• Bachelor degree in engineering or related scientific discipline required.
• 5 to 7 years of related work experience.
• Microsoft Word and Excel experience required.
• Knowledge of regulatory requirements, requirement specifications, systems qualifications and protocols, equipment operating procedures, standard operating procedures, and validation reports.
• Strong written and verbal communication skills.
• Strong organizational and time management skills.
• Able to excel both as part of a team and independently.

Responsibilities

• Manage equipment procurement process and qualify M&TE for laboratories per testing standards.
• Design and execute qualifications, requalifications and validations of M&TE.
• Analyze qualification data and generate final reports.
• Ensure equipment data handling complies with 21 CFR Part 11.
• Investigate and troubleshoots using advanced mathematical and engineering knowledge.
• Complete nonconformance, corrective action and preventative action documentation.
• Prepare, review and maintain written technical documents for M&TE, including protocols, reports, SOPs and EOPs.
• Perform raw data review for qualifications, calibrations, and equipment service.
• Write and implement change control plans and risk assessments.
• Coordinate and document scheduled/unscheduled maintenance of equipment.
• Provide training on equipment use to laboratory and support staff.

Skills

Written and verbal communication

Time management

Teamwork / collaboration

Education

Bachelor degree in engineering or related scientific discipline

Tools

Microsoft Word

Microsoft Excel

Job description

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the:

Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

Compensation Target: $115,000.00

Job Description:

• Experienced with management of equipment procurement process and aids in identifying/developing criteria for procurement/installation of new Measurement and Test Equipment (M&TE) for laboratories with respect to testing standards.
• Design and execute qualifications, requalifications and process validations of M&TE as required by appropriate Biotech and Pharmaceutical industry regulations and standards (e.g., 21 CFR Part 820, ISO 17025, etc.).
• Analyze qualification, requalification and validation raw data and generate final reports.
• Work with IT to ensure equipment that generates electronic data is complaint with 21 CFR Part 11.
• Investigate and troubleshoots using advanced mathematical and engineering knowledge.
• Complete nonconformance, corrective action and preventative action documentation.
• Prepare, review and maintain written technical documents for M&TE, including protocols, reports, Standard Operating Procedures (SOPs) and Equipment Operating Procedures (EOPs).
• Perform raw data review for qualifications, calibrations, and equipment service.
• Write and implements change control plans and risk assessments.
• Experienced with coordinating and documenting scheduled/unscheduled maintenance of equipment.
• Experienced and possesses technical aptitude required for requalifying, conducting process validations and trouble-shooting sterilizers and resistometers.
• Experienced with driving purchasing process for materials/services needed for owning departments.
• Maintain and support equipment documentation in the Equipment Management System.
• Provide training on equipment use to laboratory and support staff.
• Drive trending and analysis of TE failures.
• Experienced with installing, qualifying and maintaining Siemens monitoring points.
• Assists laboratory personnel with continuous monitoring and alarm investigations.
• Administrate and performs maintenance and upgrades of engineering software systems.
• Create and maintain Associate user accounts to all Engineering systems.
• Responsible for writing and executing building expansion validations.
• Updates/Maintains Engineering drawings for buildings, equipment and system.
• Update and maintains Engineering drawings for buildings, equipment and systems.
• Provide equipment records to appropriate staff as needed for client audits and acts as qualification/validation SME where appropriate.
• Train Associates on new and existing equipment and processes.
• Apply standard engineering techniques to improve various processes and assists the laboratories with identifying equipment needs for proactive planning.
• Ensure electronic and paper equipment files are retired/archived appropriately

Qualifications & Technical Competencies:

• Bachelor degree in engineering or related scientific discipline required.
• 5 to 7 years of related work experience.
• Microsoft Word and Excel experience required.
• Knowledge of regulatory requirements, requirement specifications, systems qualifications and protocols, equipment operating procedures, standard operating procedures, and validation reports.
• Strong written and verbal communication skills.
• Strong organizational and time management skills.
• Able to excel both as part of a team and independently.

Salary Range: $105k- $115k annually

Working Conditions:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and climb or balance. The employee must frequ