Validation manager [h1.location_city]
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Validation manager • orange ca
[last_updated.last_updated_variable_hours]
Responsible for the validation and revalidation of machines, equipment, material, and process based on defined protocols.
Will support activities to maintain and improve the quality management syste...[show_more][last_updated.last_updated_variable_days]
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ARP4754A Guidelines for development of civil aircraft and systems.Flight Control Computers and System Integration lab test setup environments.
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[job_preview.job_type]
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[job_card.job_description]Conduct IQ, OQ, and PQ trials for machine / process / material validations or revalidations. Evaluate validation results and create validation reports. Develop, update, implement, or modify machine, test, and / or process validation protocols and manufacturing parameter ranges for material combinations. Evaluate and validate new materials and / or material combinations. Create, review, and / or update machine, material, and process validation procedures. Perform other duties as assigned. Bachelor’s degree in engineering, science, or related field, associate’s degree in engineering, science, or related field, or at least 5 years of direct experience is required. 6 months related experience – this can include professional experience, internships, or organizational involvement is required. Experience in and / or knowledge of ISO standards 13485, 9001, or 11607 and / or FDA 21 CFR 820 requirements. Education and / or experience with machines, material, and / or process validations (IQ, OQ, and PQ). Education and / or experience with medical device manufacturing, medical device packaging, pharmaceutical or other regulated industry. Education and / or experience in a high-volume manufacturing environment Education and / or experience with FDA requirements for medical devices and / or cGMP practices. Education and / or experience with complaint investigations, risk assessments, root cause analysis, CAPA, Investigations, NCMR, Engineering, FDA, quality engineering, quality assurance, remediation, risk management. Education and / or experience with statistical process control, statistical quality control or design of experiments. Communication – Ability to communicate with all levels of personnel from production level operators to upper management and customers or suppliers. Diversity – Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce. Ethics – Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Technical Skills – Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others. Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan. Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Continually required to work on a computer. Continually required to stand. Continually required to walk. Continually required to sit. Continually required to utilize hand and finger dexterity. Continually required to talk or hear. Continually work near machines moving mechanical parts. Occasionally exposed to heat or cold (non-weather related). While performing some aspects of this job, the noise level in the work environment is usually very loud (the production floor is considered a sustained loud manufacturing environment that requires hearing protection). The employee may on occasion lift and / or move up to 25 pounds. Specific vision abilities to perform functions of this job may include : close vision; distance vision; color vision; peripheral vision; depth perception and ability to adjust focus. When working in the production areas this position requires the employee to wear PPE (Personal Protective Equipment) including gowning, hair nets, beard covers, eye protection, hearing protection, and any other necessary PPE. $90,000 - $100,000 per year. Medical, dental, vision insurances, 401k with company match, company paid holidays, paid time off, and sick time. This is position is fully on site.
Job Description
Job Description
DEPARTMENT : Quality Assurance
REPORTS TO : Director of Quality
SUMMARY : Responsible for the validation and revalidation of machines, equipment, material, and process based on defined protocols. Will support activities to maintain and improve the quality management system and ensure compliance with ISO, regulatory, and customer requirements.
DUTIES AND RESPONSIBILITIES :
Quality Related Requirements :
- Create, review, and / or update procedures and work instructions.
- Create, review, and / or update product specifications.
- Create, review, and / or revise quality policies, procedures, and systems to help ensure compliance with ISO, regulatory, company, and customer requirements.
- Support supplier control activities including leading or supporting onsite or remote supplier audits, assessments and / or conducting supplier surveys.
- Works with department managers to train personnel on processes and quality procedures.
- Lead and / or participate in change control activities throughout the manufacturing and operations processes.
- Support internal audit process to ensure compliance with ISO standard requirements.
- Perform root cause analysis and develop preventative and corrective actions to eliminate non-conformances.
- Support site production and engineering functions in process quality improvement activities.
- Compile and analyze manufacturing and quality metrics, analyze trends and report to quality management.
- Review, recommend, and support the implementation and use of existing or new test equipment.
- Review and evaluate tool drawings. Inspect tooling before released to production.
- Support and / or manage the NCR / MRB process.
- Develop, create, implement, maintain, and / or modify gauge R&R protocols for test equipment and personnel.
- May lead, support, or follow up on customer complaint investigations.
- Perform other duties as assigned.
Validation Related Requirements :
CANDIDATE REQUIREMENTS :
PREFERRED EXPERIENCE AND SKILLS :
COMPETENCIES :
PHYICAL DEMANDS AND WORK ENVIRONMENT :
COMPENSATION AND BENEFITS :
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Each candidate for this position must have a clean and neat appearance, observe good personal hygiene and conform to the dress code in keeping with SteriPax’s clean manufacturing environment.
I have reviewed, understand, and able to perform with or without accommodation the requirements as described in this this job description.