Roechling Medical Rochester offers customers a wide range of high-quality, customized components and assemblies, right through to end-to-end OEM products. The product portfolio also includes standard plastic products, with special expertise in the fields of diagnostics, fluid management, pharma, surgery and interventional, and much more. These areas of competence are complemented by an enhanced range of services for development and regulatory affairs, right through to approval of end-to-end medical products.
Manages Inspectors and coordinates all activities related to Quality Inspection of medical devices and components. Areas of responsibility include Receiving Inspection, In process Inspection, Floor Inspection, Clean Room Inspection and Final Inspection across all shifts. Ensures customer inspection programs are executed and customer quality requirements are achieved. Reviews customer part drawings and inspection data to ensure uniformed program compliance. Maintains close working relationships with other department managers and supervisory personnel in order to meet and maintain product quality, identify, solve, and prevent problems affecting product quality, maximize productivity, and comply with regulatory requirements. Responsible for leading process improvements within the Inspection department.
Supervisory Responsibilities:
· Assessing the work performance of Inspectors and identifying areas that need improvement.
· Train and assist to achieve standardized measurement and reporting methodologies.
· Setting goals for Inspectors and making sure they comply with the team & company’s plans and vision and complete performance appraisals.
· Listen to team members’ feedback and resolve any issues or conflicts.
· Create an inspiring team environment with an open communication culture.
· Manage the daily activities of the In-process, Floor and Final Inspectors
· Ensure in-process inspection activities are being performed per the standard operation procedures and work instructions.
· Verify that the QCCALC data collection activities are being performed per the part inspections plan through random periodic document audits.
· Ensure current inspection methods meet the min 1.33 CPK requirements for CTF dimensions and if not inform Quality Management.
· Generate inspection data required for customer shipments and ensure there is appropriate trained back-up when required.
· Develop in-process gaging at the molding to replace CMM inspection where applicable.
· Work with development to ensure PQ runs are production ready regarding in-process inspection requirements i.e., fixtures, CMM/OPG/ Keyence programs, or other measurement methods.
· Perform data collection for MSA studies when required.
· Participate in problem solving activities.
· Work with Quality Engineers to identify when improvements or updates are required for current in-process inspection work instructions.
Essential Duties/Responsibilities:
· End to End ownership over inspection processes and procedures
· Ensure that Production/In Process programs that get transferred to the QA Lab are sufficient and robust enough for ongoing use of entry-level Technicians.
· Work with Engineering to design and develop fixturing to be used during part inspection.
· Manage the budget and determine the most appropriate inspection equipment to ensure efficient and effective inspections
· Collaborate with cross-functional teams to solve problems and/or improve quality.
· Follow all safety and precautions and requirements.
· Employee training and supervision
· Distributing work assignments and supervising projects to ensure collaboration and compliance.
· Coordination of NC log/ process
· Performance evaluation and improvement
· Creation and review of Inspection procedures
Required Skills/Abilities:
· Strong management and leadership skills.
· Excellent verbal and written communication skills.
· Excellent interpersonal and customer service skills.
· Excellent customer service skills.
· Excellent organizational skills and attention to detail.
· Excellent time management skills with a proven ability to meet deadlines.
· Strong analytical and problem-solving skills.
· Ability to prioritize tasks and to delegate them when appropriate.
· Ability to function well in a high-paced and at times stressful environment.
· Proficient with Minitab, Microsoft Office Suite, or related software.
Education and Experience:
Bachelor's degree in management, engineering or related sciences.
At least five years’ related experience required.
Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift 15 pounds at times.
Visual acuity for inspections, color differentiation, reading electronic documentation.
Work Environment:
Manufacturing environment requiring appropriate eye protection.
Exposure to high noise level in the work environment requiring hearing protection.
Gowning and sanitation for manufacturing in a clean room
Roechling Medical Rochester (RMR) is an Equal Opportunity Employer. RMR does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
