Direct Hire- Permanent
Oversee and provide leadership to the Quality Inspection Department and related processes to ensure conformance to customer specifications and compliance with relevant regulatory requirements.
- Responsible for compliance with and improving the corporate Quality System in conformance to FDA and ISO standards appropriate for world-class suppliers to the medical device industry with the following areas of responsibility:
- Primary Focus:
- Develop and supervise in-process and final inspection processes.
- Manage the resolution of all product rejections and returns, internal and external, call and follow-up on Material Review Board Meetings.
- Responsible for inspection department, including scheduling, prioritizing work, hiring, and assessing individual performance with respect to individual, department, and corporate goals.
- Other Essential Functions
- Manage activities to ensure timely response to all customer-inquiries including complaints, customer generated Supplier Corrective Action Requests (SCAR's), and Pulse Systems issued SCARs.
- Track and manage the timely resolution of all customer inquires, open SCAR's.
- Corrective and Preventive Actions
- Ensure Corrective And Preventive Action (CAPA) activities are initiated when required.
- Monitor CAPA activities from initiation, through closure, and verification of effectiveness.
- Internal Audits - Participate in and/or perform internal quality audits.
- Third Party Audits Participate in external quality audits and surveys from customers and regulatory agencies.
- Train employees, including management, in quality processes and regulatory requirements.
- Monitor internal training activities to ensure employees are trained in accordance with Pulse Systems procedures.
- Document Change Orders
- Work with other departments to define, qualify, and implement Document Change Orders.
- Manage the Document Control process to maintain revision control on all internal controlled documents.
- Ensure that Document Change Orders are tracked and implemented in a timely manner.
- Support the execution of production schedules consistent with company goals and objectives. Coordinate support from other staff and production personnel as necessary.
- Be a company champion for quality and compliance.
- Prepare materials for and participate in Quality review meetings with management.
- Adhere to general safety rules, manufacturing procedures, company policies and procedures and other ISO guidelines.
- Work from limited direction as set by the Head of Quality (currently Director of Engineering and Quality).
Perform other duties as assigned.
1. Education and Training
- A technical undergraduate degree; industry experince may be substituted to provide qualification for the position.
- A minimum of 7 years of related experience, preferably including: Quality Engineering and/or inspection supervision in a manufacturing or job shop environment, knowledge of medical device manufacturing and related regulatory requirements.
- Ability to lead by example and manage people and processes in a demanding contract manufacturing environment.
- Flexibility, adaptability, judgment, and ability to work under pressure to meet schedules and deadlines within quality and regulatory standards.
- Excellent interpersonal skills; ability to adapt to changing corporate priorities; and ability to maintain good working relationships while dealing appropriately with a variety of contacts within and outside the organization.
- Ability to work with customers at all levels of the client's organization.
- Ability to read blueprints, engineering drawings and sketches, make informed management and technical decisions is required.
- Ability to work independently, using good judgment, initiative and problem-solving abilities, to follow detailed verbal and written instructions, anticipate likely needs and take appropriate actions, while working with minimal direction.