Position Title: Quality Engineer / Inspection Supervisor
Direct Hire- Permanent
Compensation: $70k-$100k/year

Responsibilities:
Oversee and provide leadership to the Quality Inspection Department and related processes to ensure conformance to customer specifications and compliance with relevant regulatory requirements.

Essential Functions:
  • 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:
  • Inspection:
  • 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
  • Complaints/SCARs
  • 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.
  • Audits
  • 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.
  • Training
  • 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).

Other Responsibilities
Perform other duties as assigned.

Qualifications:
1. Education and Training
  • A technical undergraduate degree; industry experince may be substituted to provide qualification for the position.
2. Required Experience
  • 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.
3. Essential Skills and Abilities
  • 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.