Position Summary The Manager, Quality and Compliance, coordinates the activities required to meet quality standards and is responsible for ensuring that the product and service provided meet both the specification and customer expectations. The Manager, Quality and Compliance, will work with other managers and staff throughout the organization to ensure that the Quality Management System is functioning properly and is continuously improved, as opportunities are identified. This position is responsible for the oversight or performance management of other employees.
Essential FunctionsReasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Quality leader for all HPMS divisions.
- Fully maintain and continuously improve a Quality Management System consistent with the latest revisions of ISO 13485 and FDA requirements as applicable, acting as the Subject Matter Expert
- Acts as the Management Representative for both the ISO 13485 and the ISO 9001 Quality Management Systems. Within this responsibility the Manager, Quality and Compliance is responsible for presenting Management Review in accordance with both ISO standard requirements.
- Oversee and manage Quality Control functions, with direct authority over QA Engineers, QA Supervisors and support staff, QC inspection Supervisor, and indirect authority over non-quality department personnel performing system and process audits.
- Recommend strategies and tactics to improve QC inspection methods. Drive test procedure development, equipment evaluation, implementation, and analysis of quality measurements to improve facility performance.
- Establish clear and achievable quality objectives, through both multi-year strategic and annual tactical planning activities for Quality System improvements and Quality related Key Performance Indicators
- Establish and prepare quality metrics, monitoring performance by gathering relevant data and producing statistical reports to advise on the performance of the quality management system.
- Establish and maintain performance, safety, and reliability testing and category protocol by incorporating test procedures as required by Design Engineering, Customers and Regulatory Agencies.
- Conduct product testing and failure analysis by collecting, analyzing, and summarizing information and trends including failed processes, capability studies, recalls, and corrective actions (8D Process).
- Drive continuous improvement through innovative methods, such as Lean and Six Sigma, providing quality improvement expertise and leadership to other departments.
- Maintains and improves product quality by managing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to ensure customer expectations are always considered.
- Oversees NCR's, Customer Complaints, and CAPA completion for both ISO quality systems.
- Manages Suppliers NCR's, CAPA, and Supplier Audits for both ISO quality systems.
- Manages internal audits, customer audits and register audits for both ISO quality systems.
- Oversees the controlled document process to ensure compliance with relevant standard and internal requirements.
- Manages and maintains corporate procedures as applicable.
- Manages and oversees software validation as applicable for the ISO 13485 system as required.
- Light lifting, carrying of files, supplies, ability to move, carry and/or lift up to 25 pounds.
- Obey all safety rules, use caution in work activities, and continuously practice safe behaviors.
- Immediately report unsafe conditions/behaviors and work-related injuries to site supervision.
QualificationsRequired
- Minimum 10 years' related experience in a controlled manufacturing environment or relevant experience
- Familiarity with quality standards and processes (ISO 13485 & ISO 9001 specifically).
- Communication skills to convey information in reports, meetings and status reports.
- Knowledge of the product to perform accurate quality control.
- Must pay great attention to detail.
- Analysis, critical-thinking and problem-solving skills to review systems, find flaws and pose solutions to those flaws.
- Strong interpersonal skills are necessary.
- Ability to handle stress in an appropriate manner.
- Ability to operate under deadlines while still meeting standards.
- Strong data analysis and statistical aptitude are necessary.
- Proficient skills working with Microsoft Office, Minitab or similar.
Preferred
- BS degree in Engineering preferred, and/or equivalent experience.
- ASQ: CMQ/OE, CQE or CQA preferred.
