General Information:
- Company: Plexus Corp (Design Center), Boulder, CO
- Position: Quality Systems Administrator II
- Auto Req ID: 4308BR
Job Overview:
- Provide support and leadership within the Quality Services department and engineering operations in order to effectively monitor and maintain a compliant quality system capable of meeting business needs.
- This position can be located at the Boulder, CO or Neenah, WI Design Center
Responsibilities:
- Support, promote and report corrective and preventive action activities
- Ensure regulatory compliance
- Support Quality Services continual improvement activities
- Work with owners of corrective action issues to ensure resolutions is implemented in a timely manner according to defined performance goals. Emphasize the importance of accurately defining the situation, root cause, and corrective action plans prior to implementation. Confirm that supporting documentation reflects actions taken
- Drive effective and timely implementation of corrective actions relative to functions performed by quality Services
- Generate corrective/preventive action reports as requested by management
- Remain abreast of new and ever-changing applicable quality system standards and regulatory requirements
- Communicate and educate personnel on the changes as they are released to industry. Promote awareness of changes to ensure quality system processes are appropriately reviewed and updated to maintain compliance with quality system standards and regulatory requirements.
- Assists, and occasionally lead, the creation, maintenance and implementation of quality system procedures to ensure processes consistently produce high quality results and meets applicable standards and regulatory requirements
- Update procedures relative to the Quality Services department as needed
- Serve as reviewer to standard operating procedures to ensure regulatory compliance is maintained
- Demonstrate strong knowledge and understanding of Plexus’ standard quality policies and procedures
- Provide input into the growth and development of the quality system and its processes
- Directly interface with internal customers to clearly and concisely communicate quality system standards and regulatory requirements
- Conduct internal audits
- Lead the development, communication and execution of an audit strategy and schedule
- Conduct internal audits to evaluate the effectiveness of the quality system and identify areas for improvement
- Generate internal audit reports and monitor related corrective and preventive action to ensure effective and timely resolution
- Identify trends and provide recommendations for improvement
- Lead the implementation of basic auditing tools and techniques to an audit, such as flowcharting, observation techniques, physical examination and sampling theories
- Participate in agency and customer audits as requested Ensure timely response and follow through on corrective actions to audit findings
- Identify and promote Quality Services objectives to ensure departmental goals are achievable and successfully attained
- Minimal travel may be required to support the needs of other design centers
Skills & Abilities:
- Intermediate computer skills
- Advanced decision making and problem solving skills
- Advanced verbal and written communication skills
- Possess good interpersonal skills
- Possess good organizational skills
- Possess expert knowledge of ISO9001
- Possess expert knowledge of the FDA Quality System Regulation
- Possess expert knowledge of ISO13485
Education & Experience:
- A minimum of a Bachelor’s degree in Quality, Auditing, or business related field and 4 years equivalent industry experience,
- or minimum of 10 years of related industry experience is required for this position
Qualifications:
- All candidates must have the legal right to permanently live and work in the United States without sponsorship
Application:
Interested candidates should review the requirements and apply online
- at Plexus careers via following Recruiting Process Step 1. Application Submittal
- Apply and upload your resume to the specific position you’re interested in.
- Click on “United States” link
- then enter Auto Req ID: 4308BR to see and apply for this position
Or via the Direct jobs.brassring.com posting: Quality Systems Administrator II at Plexus Corp, Boulder, CO
