Quality Systems Engineer
Quality Systems Engineer
Phillips-Medisize, LLC is seeking a Quality Systems Engineer to serve as global resource and subject matter expert to manage Divisional Quality Management System, European QMS and regulatory requirements for cGMP, ISO13485.
- Work closely with global sites to implement the Quality Management System standardization and integrate with the ERP system implementation and maintenance.
- Develop meaningful metrics to gain understanding of current state of QMS and manage the monthly KPI review process
- Participates in audits and regulatory inspections
- Provide GMP guidance to facility personnel
- Support product compliance by working with the Quality organization.
- Evaluate processes for updating techniques, quality and overall efficiency to improve operations
- Instill a mindset that will proactively cause those involved in the business to put all GMP regulations at the forefront of their day-to-day activities
- Regularly research and evaluate regulatory trends to insure the compliant systems
- Provide periodic status updates and reports
- Reviews regulatory, program and customer requirements ensuring early quality involvement in program development
- Travel to PMC facilities as required to support business needs
- BS plus a minimum of four years of related experience within a regulated environment, or equivalent industry experience
- Knowledge of GMPs Regulations (13485, 820, 210/211, EU)
- Internal Auditor (external lead training preferred)
- Strong communication, teamwork, and organizational skills
- Ability to manage small projects/programs with limited assistance from others
- Knowledge of FDA Quality System Requirements, ISO 13485, ISO 9001, ISO 14971 and other medical device regulations, both domestic and international.
- Must interact with all levels of managements, co-workers, and regulators
- Leadership skills including ability to lead, mentor, and maintain confidentiality
- Strong written, verbal and interpersonal communication skills
With your application, you agree that your information will be recorded in our files (up to 6 months after finalizing the position) and if necessary, forwarded to affiliated companies.
We are an equal opportunity employer.
The Company – in short
Phillips-Medisize, LLC, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device and specialty commercial markets.
Read more about Phillips-Medisize A/S at www.phillipsmedisize.com or follow us at LinkedIn.
To apply for this job please visit sjobs.brassring.com.