Quality Compliance Manager

Quality Compliance Manager

The Quality Compliance Manager has an important leadership role within the quality organization and reports to the Director of Quality. This role will entail actively leading the daily operations of the internal quality compliance technical staff, who manage the Hollister's site's compliance initiatives, including but not limited to: external AS9100 and/or ISO9001 certificates and associated customer-initiated audits, all US Government (DCMA, MDA, etc.) compliance and process audits including Government Corrective Action Requests (GCAR) responses, Customer Corrective Action Requests (CCAR) responses, and Internal Corrective Action Requests (ICAR) responses, and all other associated activities.

As a manager, this position requires a balance of quality leadership and partnering with the Operations Quality, Quality Inspection and Supplier Quality managers and technical staff to ensure timely and effective resolution on critical quality issues impacting site compliance activities.

Responsibilities

Key roles and responsibilities will include:

• Support the development and implementation of robust career development plans for compliance quality engineering – and other technical staff as required, including skill set development, cross-training, prioritization of development goals and providing them with promotional advancement opportunities within the quality organization
• Customer Relationships – Build, maintain and optimize the compliance organization's key role in relationship management with our critical customers, including DMCA, MDA, Lockheed, Raytheon, Boeing, General Dynamics and non-US based customers
• Develop, implement and optimize new employee onboarding standard work and procedures for compliance quality engineers in the quality organization
• RCCA – Ensure that each compliance quality engineer is thoroughly proficient in their understanding and application of causal analysis tools and methodologies, allowing the quality engineer to lead multi-disciplinary teams through complex root cause investigations in an expedited manner to support daily site operations
• KPIs – Develop and advocate and maintain for critical Key Performance Indicators for the compliance function within the overall Quality organization
• Artificial Intelligence – Provide training on effective metric usage and ensure their consistent application and refinement for all quality engineering functions with the goal of supporting future automation AI (Artificial Intelligence) of collection, analysis and metrics optimization to enhance the effectiveness of the quality compliance organization
• Support the planning and realization of future strategic quality process and day-to-day enhancements processes by championing the incorporation of industry-leading automated quality compliance capabilities – including incorporation of AI for compliance (process, procedure, etc.) risk identification, read-across (to other departments, functions, or other Ralliant Operating Companies) and risk mitigation, with the goal of optimizing external/internal audits
• Multi-site Leadership – Assume Compliance leadership role for non-CA sites, including Solon (Cleveland), OH, and possible future sites
• Act as a facilitator and provide Quality leadership support during internal and external Quality Audits (AS9100D), and for Customer PPB (Production Process Baseline Assessment) audit, and US Government audits as necessary
• Embrace and execute additional responsibilities as they arise
• Role requires working supporting operations via 5 day 8-hr workweek and supporting quality weekend staff

Minimum Qualifications

• BS Degree in a technical engineering or quality-related field or comparable work experience in Quality-related fields A minimum of 10 years' experience in quality-centric roles such as: compliance quality, operations quality, program or platform quality, or supplier quality. Note: Mfg. Engineering leadership experience may be considered in lieu of dedicated Quality experience.
• Proficient knowledge of Quality Engineering principles and practices
• Expert knowledge and experience with AS9100D, ISO9001:2015 and other industry quality standards
• Proficient in corrective actions and problem-solving methodologies (CAPA) to allow you to serve as "train-the-trainer" in causal analysis and continuous improvement activities
• Proficient knowledge of Lean operations/process engineering principles
• US Citizenship
• Preferred: Advanced degree in a technical engineering, quality or operations-related field
• A minimum of 5+ years' experience as a Compliance or Quality Manager. Note: Mfg. Engineering leadership experience may be considered in lieu