Description
Quality Manager
Springfield, MO
Description
Position Summary:
The Quality Manager leads the Quality team with implementation of company-wide operations procedures and process to support the overall Quality Assurance plan. This role support Quality improvement throughout the shop floor and within the team concept. Participate as cross-functional team member within assigned goal oriented team responsibility.
Responsibilities:
- Oversee all Quality staff.
- Coach, develop and provide guidance to Quality staff.
- Ensure cross-training of all Quality staff, so that all internal and external (service/installation) needs can be met.
- Drive efficiency and productivity within the team.
- Review and evaluate site Quality staff performance.
- Support and maintain ABEC Key Initiatives and Core Values.
- Support and maintain the ABEC Quality program.
- Maintain and ensure compliance to ABEC Standard Operating Procedures (SOPs).
- Support and maintain ABEC quality practices and guidelines, including best industry practices such a Good Documentation Practices (GDP).
- Participate in internal, process and mock customer audits, as directed.
- Perform vendor qualification or re-qualification audits, as directed.
- Coordinate 3rd party audits of specified site as directed (ASME, National Board, etc.).
- Coordinate and support Customer audits of the ABEC site, as directed.
- Site liaison with Authorized Inspection (AI) Agency personnel (Vessel Manufacturing sites only).
- Coordinate team involvement in Pre-FAT, FAT, SAT, and IQ/OQ activities as required.
- Corrective Action & Preventive Action (CAPA).
- Coordinate assigned CAPA activities (Root cause analysis, short & long term corrective and preventive actions).
- Serve as a site CAPA mentor for assigned champions from other functions.
- Coordinate assigned Continuous Improvement initiatives, driving both cost and process improvements.
- Coordinate Quality System Change Management assignments as directed.
- Coordinate calibration activities at specified ABEC facility.
- Report to the Global Director of Quality the status and metrics of the quality program for the specific site.
- First Pass Yields (from monitored Mfg. Processes).
- Turnover Package (TOP) Audits.
- ECN Reviews.
- MRB cycle times.
- Receiving Inspections.
- Trend analysis of FAT/SAT punch list items.
- Maintain documents in ABEC archives.
- Execute other tasks as assigned.
- Ability to travel when required.
Requirements
Required
- Bachelor’s Degree in an Engineering discipline or related Science field (ex. Chemistry, Metallurgy).
- Minimum 5 years post graduate work in a Quality or Validation fields.
- Minimum of 5 years of leadership experience in a manufacturing environment.
- Proven ability to lead, supervise and coach a team of 10 quality staff.
- Report to the Global Director of Quality the status and KPI metrics of the quality program for specific site such as First pass Yields (from monitored Mfg. Processes).
- Turnover Package (TOP)Audits, ECN Review, MRB cycle times, Receiving Inspections, Trend Analysis of FAT/SAT punch list items.
- Experience with Corrective Action and Preventive Action (CAPA) is required.
- Coordinate assigned CAPA activities (Root cause analysis, short and long term corrective and preventive action).
- Certifications in cGMP, ISO 9000, ASME, BPV or equivalent is required.
- Must be able to travel domestically and internationally.
Preferred
- Review and evaluate site quality staff performance experience is preferred.
- Experience with Site Liaison with authorized inspection (AI) Agency personnel (Vessel Manufacturing sites only) is preferred.
- ASQ CQE, ASQ, CQM and Six Sigma would be a plus.