Main duties will revolve around equipment validation for their lab, but it is a small team so you will get exposure to all aspects of Quality Engineering.
ESSENTIAL DUTIES AND RESPONSIBILITIES
IQ, OQ, PQ of equipment and equipment validation for the lab move. The position is responsible for ensuring that quality audit programs and regulatory submissions comply with external regulations.• May manage document control process to ensure the process follows internal requirements and it is adequate.
• May manage the training process to ensure the process follows internal requirements and it is adequate.
• May manage the quality control process (incoming and final release)
• Interface with internal constituents and external regulatory bodies regarding compliance needs as required
• Assist in the preparation of the Management Review meeting presentations on a quarterly basis
• Report on quality systems in quarterly Management Review meetings
• Prepare and coordinate regulatory filings such as IDE, PMA and Design Dossier submissions and
subsequent revisions/supplements and amendments
• Attend project team meetings on a regular basis and provide assistance with regulatory strategies for various projects
• Review and approve complaint investigations
• May review and approve Non-Conformances and CAPAs investigations.
• Prepare international product registrations and licensing documentation
• Provide continued quality system support by improving processes and systems and by updating and creating site procedures.
• Participate in third party (Notified Body, FDA) audits as required
• May manage key quality system programs such as CAPA, environmental monitoring, CER recertification, and shelf life establishment
• Provide support to manufacturing lines to address issues and escalate issues to NC or CAPA process as needed.
• Ensure Site Metrics are complying with internal requirements and goals established
• Work with medium complexity projects to ensure process improvement is continuously followed
• May provide coaching to technicians to promote people development and process improvement culture
• Responsible for communicating business related issues or opportunities to next management level
• For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety an Environmental practices and that all resources needed to do so are available and in good condition
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
• Performs other duties assigned as needed
Additional Skills & Qualifications
• Bachelors Degree in related discipline and a minimum of 5 years in the medical device/pharmaceutical field, or equivalent combination of education and experience.
• Expertise in the FDA Medical Device Quality system Regulation, MDD 93/42/EEC and ISO 13485
• Experience and involvement in MDRs, IDEs, PMA, and 510(k) filings is preferred.
• Excellent oral and written communication skills
• Proven ability to create improvements in processes and systems
• Effective interpersonal skills
Pay and Benefits
The pay range for this position is $50.00 - $60.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Santa Clara,CA.
Application Deadline
This position is anticipated to close on Aug 22, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.