Sr. Quality Systems Engineer:Principle Duties and Responsibilities:
- Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system.
- Oversee the company's Internal Audit system, including tracking and follow-up on all audit findings.
- Organization of quality data (Manufacturing, CAPA, etc) for trending and reporting.
- Support and/or lead 3rd party audits, including follow-up on actions.
- Partner with Process owners to generate and metrics, which reflect the health of different Quality System elements.
- Support Internal Audit program, e.g., participate/lead Internal audits, follow up on the finding with auditee through effective closure, present the data for trending, etc.
- Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).
At Advantage Resourcing, our primary objective is to perfectly align the best people with the appropriate jobs. These jobs may be temporary assignments or career positions. We place talented people in a wide variety of jobs working with our client companies in areas such as: engineering, IT, technical, manufacturing, skilled trades, distribution, call centers, clerical, accounting, finance and sales.Our strength is being able to solve our client's workforce needs by matching people that have the right skills, knowledge and motivation to each opportunity. Advantage Resourcing can help you discover the personal and career success you desire.Advantage Resourcing Americas, Inc. is an Equal Opportunity Employer offering employment without regard for race, color, religious creed, national origin, ancestry, gender, marital status, age, sexual orientation, sex, gender identity, disability, veteran status, or other legally protected categories. Advantage Resourcing is a VEVRAA Federal Contractor.
- CAPA Management
- BS Degree or equivalent
- Experience in FDA regulated industry (Medical Device/Pharma)
- Internal/External Audit (front/backroom experience)
- EU MDR Cert
- SAP highly preferred