Corporate Quality Manager
SP Industries is seeking a talented, process oriented Corporate Quality Manager. This position will report to the Chief Operating Officer and will be responsible for leading and driving quality improvement initiatives across the organization, maintaining and enhancing the quality management system, and working with the manufacturing plants to comply with all applicable regulatory and compliance requirements.
The ideal candidate will have extensive experience with capital/process equipment manufacturing, and all of the associated regulatory, compliance, and GMP quality processes for an ISO 9001:2015 quality management system. This leader’s primary responsibility will be leading the quality engineering and quality control functions, while at the same time working across the organization to improve the quality management system, manage the corrective action process, and non-conformance process. This leader will also coordinate with the filed service and final test teams to evaluate and enhance the overall quality of SP’s Equipment.
SP Industries, Inc., is a leading designer and manufacturer of state-of-the-art laboratory equipment, pharmaceutical manufacturing solutions, laboratory supplies and instruments, and specialty glassware. SP's products support research and production across diverse end user markets including pharmaceutical, scientific research, industrial, aeronautic, semiconductor and healthcare. Headquartered in Warminster, Pennsylvania, SP Industries has production facilities in the USA and Europe and offers a world-wide sales and service network with full product support including training and technical assistance.
Essential Duties and Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Provide regulatory affairs support to design teams and the document control/change request system
- Refreshes training for current company associates and trains new associates.
- Prepare Technical File, CE Mark, and other related regulatory filings
- Assist with preparation of U.S. regulatory submissions, Design Dossiers for European Union submissions, technical files, reviewing design control documents, and being an active member of design teams representing the regulatory affairs responsibility
- Develop, document, and implement regulatory strategies for new technologies and product modifications to include all applicable regulatory requirements
- Maintain and updates guidelines relating to international and domestic regulations for finished products and raw materials: ROHS / REACH / CM / F-Gas / ASME / PED etc.
- Provides regulatory documents in compliance with customer and country-specific requirements.
- Works in partnership with manufacturing and QA/QC in enhancing quality management systems to facilitate overall regulatory compliance
- Drafts, maintains, and updates regulatory guidelines, positions, SOPs for the department.
- Perform daily quality audits of product & process to ensure products are manufactured to established specification
- Interprets and implements quality assurance standards
- Collect and compile information to provide reporting on all inspection results, vendor scorecard data and communicate to organization members
- Establish and maintain regulatory standards, procedures and controls.
- Perform internal audits or products and procedures and take corrective action as needed.
- Manage and maintain compliance with regulatory bodies.
- Identify and implement best practices to optimize product quality and improve efficiency.
- Supervise inbound-inspection personnel for vendor and customer provided products.
- Other duties as assigned.
To perform this job successfully, an individual should possess the minimum qualifications cited.
Education, Experience, and Work Skills
Qualifications: Education, Experience, Skills, and Certifications
- Bachelor’s Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage
- Minimum of 5+ years of experience in a Medical Device, Process Equipment, Automotive or regulated manufacturing environment
- Minimum of 4 years of experience and a proven track record of successfully creating and managing a highly talented, engaged and performing team
- Demonstrated leadership ability to develop and implement organization and functional strategies; Initiates, sponsors and implements change with a demonstrated track record in QA Improvement.
- Expert working knowledge of regulatory requirements, standards and regulations, with experience managing ISO 9001 or ISO 13485 quality audits
- Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools
- Must be able to work in a team & individual environments, interacting effectively at all levels, and across all functions with ability to develop organizational relationship and build trust
- Demonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions. Works with a sense of urgency at all times
- The candidate must be highly organized, disciplined, and be able to demonstrate their ability to meet deadlines
- Previous experience in regulatory, compliance, quality processes required
- Strong analytics and structured problem solving experience
- Thorough understanding of ISO standards and conformance
- Strong project management skills
- Ability to interact effectively with internal and external customers
- Excellent people skills with the ability to evaluate, coach, and motivate employees
- Proficient in the use of MS Office, Outlook, Word, Excel and PowerPoint applications
- Knowledge of Agile methodologies
- Excellent verbal and written communication skills
- Able to understand and review technical documentation, including project plans, test procedures, and design documents
Certificates, Licenses, Registrations
- ASQ Certification preferred (CQM, CQE, CQA)
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The employee is regularly required to talk and listen.
- The employee is regularly required to use color vision and adjust focus between near and far objects.
- The employee is regularly required to stand, walk, climb, crawl, bend and sit.
- The employee is regularly required to use normal office tools, equipment and PC's.
- The employee is regularly required to handle shop tools and equipment controls.
- The employee is regularly required to use of arms and hands to climb and balance.
- The employee is regularly required to use the following senses: sight (close, distance, color, peripheral and depth perception), hearing talking, taste and smell.
- The employee may be required to lift up to 70 pounds, occasionally moving larger objects with assistance.
- The employee is occasionally required to work in tight spaces with difficult access.
- The employee is occasionally required to work from ladders, lifts or scaffolds.
- The employee is regularly required to handle tools utilizing various energy sources- low and high voltage, pneumatic, hydraulic -of low to high power.
The work environment characteristics described here are typical of those an employee might encounter while performing the essential functions of this job.
- Work is normally performed in both the office and the shop.
- The office environment is an interior office with air conditioning.
- The shop contains mobile equipment, machinery, and high voltages.
- The shop noise level is variable and may require hearing protection in some areas.
- The shop is heated when required but many areas are not air conditioned.
- Some shop processes use high voltage arcs or concentrated magnetic fields.