Senior Quality Engineer

North American Science Associates, Inc.; Irvine (CA); Sur place; USD 92 000 - 102 000; Plein temps

Avantages offerts par ce poste

Equal opportunity employer

Fair Chance Employer

Résumé du poste

NAMSA in Irvine, CA is seeking an experienced Equipment Qualification Specialist to lead procurement, installation, and qualification of laboratory M&TE in line with regulatory standards. You will design and execute validations, analyze data, and generate detailed reports for audits.

Responsibilities also include coordinating maintenance, ensuring 21 CFR Part 11 compliance for electronic data, and driving change-control activities with cross-functional teams.

Qualifications

• Bachelor degree in engineering or related discipline required.
• 5 to 7 years of related work experience preferred.
• Knowledge of regulatory requirements and validation protocols.

Responsabilités

• Manage procurement, installation, and qualification of M&TE for laboratories.
• Design/execute qualifications, requalifications and process validations per 21 CFR Part 820, ISO 17025, etc.
• Analyze qualification data and generate final reports.
• Ensure 21 CFR Part 11 compliance for equipment generating electronic data.
• Coordinate maintenance and upgrades; create CAPA and change-control plans.
• Write SOPs/EOPs and maintain equipment documentation in MMS.

Connaissances

Equipment procurement

M&TE qualifications

Process validation

Data analysis

Documentation/compliance

Troubleshooting

Change control

Training and mentoring

Regulatory awareness

Formation

Bachelor degree in engineering or related scientific discipline

Outils

Equipment Management System

SOPs/EOPs writing

Description du poste

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 theMission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our coreValues: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:$101,583.00Job 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 appropriatelyQualifications & 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: 92-102k annuallyWorking 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 frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.The compensation grade range for this position is:$68,800.00 - $133,700.00AnnualPlease Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.NAMSA is an equal employment opportunity company.NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.Fair Chance Employment Statement:At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:• May operate equipment• Records data timely and accurately• May analyze and interpret data• Conducts studies on medical devices that have an impact on human lifeA criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.