Quality & Regulatory Systems Manager
The Quality and Regulatory Systems Manager is responsible for implementing and overseeing the Vollrath Quality Management System and related systems/tools across all facilities and functions to lead initiatives that will improve the capability, predictability and reliability of all business systems and processes.
This role leads and coaches Quality teams to deliver performance improvements and risk reduction activities. Additionally this role will establish and maintain effective relationships with all other business functions of Vollrath to drive any regulatory compliance requirements.
- Manage the preparation, implementation and maintenance of the Quality Management System (QMS) to comply with the ISO 9001, FDA and other regulatory certification requirements.
- Serve as the SME (Subject Matter Expert) for the QMS processes and support systems/tools.
- Standardize processes and ensure global compliance to drive internal efficiency for teams.
- Deploy standardized business processes and procedures across all facilities and business functions.
- Lead and facilitate audits for Vollrath’ s QMS, customers, outside certification bodies (such as UL, NSF, FDA, etc) and ISO 9001.
- Identify, develop and deploy common performance metrics and support tools across the company and help teams utilize these metrics to identify improvement projects that will reduce waste across the value chain. Including but not limited to warranty, scrap, rework, cost of poor quality etc.
- Identify high impact and repetitive issues and risks affecting the QMS and engage members of the executive team to support necessary actions.
- Establish and assist with Quality initiative support of projects that improve and standardize Vollrath’s QMS.
- Understand, configure and test any QMS related systems/tools in conjunction with the functional process owner(s).
- Collect and perform data analysis, identify and document process gaps, recommend and implement process and system/tool improvements
- Provide quality metrics and analysis for the senior management team regarding company performance in areas related to internal and external customer satisfaction.
- Serve as the Point of Contact for all end users regarding inquiries about any QMS related systems/tools.
- Train and educate end users on any QMS related systems/tools and processes.
- Organize and conduct testing in any QMS related systems/tools.
- Create and maintain documentation such as functional specifications, process flows, and SOP’s for any QMS related systems/tools and processes.
- 7 years of Operations, Quality or Project Management experience within an ISO 9001 / IATF 16949 certified company.
- Bachelor’s Degree in Engineering, Business, Industrial Technology, Project Management OR 8 years related experience in the Operations function within a similar working environment
- Advanced degree in Engineering, Business, Industrial Technology, Project Management is preferred.
- ISO 9001 and/or IATF 16949 Lead Auditor
- Ability to drive and implement activities across teams and individuals to meet customer quality expectations;
- Experience collaborating with multiple sites and functions to drive common solutions;
- Proven track record of successfully managing shifting deadlines and priorities in a fast paced environment
- Demonstrated ability to influence including the ability to identify creative and effective solutions and the ability to ask the right questions, help frame logical conclusions
- Strong verbal and written communication competencies
- Ability to compile, review and analyze data with Excel, including macros, pivot tables and formulas;
- Understanding of (and some experience) with process/product launch and improvement tools including: APQP, PPAP, FMEA, Process Control Plan, Process Flow and Value Stream Mapping
Company Culture Requirements
- Treat all people with Respect - People matter. Understand your audience and your impact. We are better when people are heard and valued for their unique perspective.
- Take Ownership - People are counting on you. Act with integrity and follow through on commitments.
- Empower Action - We succeed when we work together. Our differences make us stronger and create better outcomes. People and teams are empowered to make decisions and take action.
- Commitment to Stakeholders - We are committed to knowing and exceeding the expectations of our customers, employees, ownership and communities.
- Life Beyond Work - People need balance. Embrace opportunities to pursue your passions.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex,sexual orientation, gender identity or expression, age, national origin, disability, marital status, citizenship, national origin, genetic information, protected veteran status or any other characteristic protected by law.