Quality Systems and Compliance Director
Job Summary:
The Quality Systems and Compliance Director/General Manager is responsible for developing and leading Quality Systems architecture/strategy and managing continuous improvement to compliance profile. Oversight of teams to deliver systems, programs and lead Quality System Reviews to ensure our customers’ quality expectations are met. The Director will be a change agent that works closely with Leaders in all other areas to initiate and drive a PENA Quality Culture. The individual will direct teams and work closely with Quality Operations, Quality Engineering, Quality Supplier Management, Customer Experience, Continuous Improvement and lead CAPA Board actions with accountable teams in Manufacturing, Maintenance and Engineering to resolve customer and internal issues.
- Lead and manage the Quality Systems and Compliance team organizational activities and established priorities to meet company and department goals and objectives.
- Develop high performing team and future leaders by coaching and improving individual capability through performance management systems, processes and talent acquisition.
- People leader responsible for maintaining and improving employee morale to minimize attrition.
- Establish and monitor the team’s performance ensuring aligned KPIs to the organization’s strategic objectives and with all other functional groups while ensuring compliance to company policies.
- Plans and administers department budget, capital expenditures and direct/indirect labor costs by maintaining inventory and head count controls.
- Drives digital transformation quality work streams with IT and Operations to ensure Quality Systems Platforms are integrated with production and distribution to ensure proactive and predictive quality assurance and quality operations transaction interfaces.
- Ensures Quality Systems operate in state of sustained compliance to capture, measure, report and correct, issues throughout the manufacturing process and prevent severity 1 escapes to the customer.
- Participate in new product and strategic project development to ensure PENA quality requirements are established.
- Manage company compliance profile to achieve continuous improvement objectives that meet Business Plan targets creating a competitive market advantage.
- Facilitates and coordinates the flow of information necessary to plan and evaluate production performance to established Quality KPI’s (FPY, Quality, Cost, Loss/scrap, Delivery etc.).
- Orchestrates executive Quality Systems Management Reviews to meet Quarterly reporting requirements and monthly CAPA Boards that drive action items to completion.
- Champion total quality excellence and quality first behaviors, transparency and collaboration to internal and external stakeholders
- Leads all quality management systems activities, systems up-grades, internal/corporate audit, customer audits, external audits and certifications to applicable industry standards integration such as, IATF 16949:2016, ISO 9001, 14001, 45001, etc. required for all vehicle manufacturers suppliers.
- Prepares reports, charts, graphs, and other statistical information to teams conducting failure investigation and corrective action for customer related failures.
- Provide leadership during problem resolution events and management of change opportunities.
- Champion and support all corporate Quality initiatives and be a key player in the local leadership team for all issues
- Ability to travel as required of the position and other duties may be assigned
Personal Protective Equipment (PPE) Requirements:
To ensure the health and safety in the workplace and for the protection of our employees, wearing PPE is a possibility and may include equipment such as a full Tyvek suit, safety shoes, gloves, safety glasses, face mask, bump cap, and a full hazmat suit that includes a respirator.
The foregoing description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills and efforts or work conditions associated with the job. It is intended to be an accurate reflection of the general nature and level of the job.
Qualifications: Requirements - Required and/or Preferred
Education:
- Basic: MS, MBA or Bachelor’s Degree in Quality, Reliability, Engineering or related field
Essential Qualifications:
- 10+ years minimum Quality Systems and Compliance experience required in a high-volume manufacturing environment (1M+ units per day) including industries such as batteries, semiconductors and medical devices.
- Extensive experience utilizing quality management tools including: statistical decision-making methods, process capability analysis, Measurement System Analysis (MSA), Gage Repeatability and Reproducibility (GR&R) and Design of Experiments (DoE)
- Extensive experience in continuous improvement and structure problem solving techniques and tools such as 8-D, fishbone, FTA, FMEA and other quality tools
- Knowledge of 6 Sigma methods and techniques, process control systems, process capability, measurements and analysis, FMEA, preventive action, and continuous improvement programs required
- Must possess strong verbal and written communication skills including strong customer service skills.
- Must communicate appropriate information accurately and clearly in compliance with legal proprietary disclosures as needed.
- Must have strong presentation skills with the ability to effectively and appropriately interface and communicate with a variety of individuals or groups on a frequent basis (customers, corporate teams, executive leadership and internal employees etc.).
- Ability to build good interpersonal relationship with peers, direct reports, and customer.
- Proficient in MS Office Suite, especially Excel, PowerPoint and Outlook
