This position is an excellent opportunity for a Senior Quality Engineer that has been in a lead role, has mentored others, or with people management. This position will be responsible for the quality compliance for class III medical devices in commercial manufacturing. The position will focus on Quality Engineering & Inspection for Commercial manufacturing
This position will be responsible for the Leadership and management of all site-level Quality-organizational personnel and resources to ensure adherence and compliance to the company’s Quality Management System. The Site Quality Manager shall be the designated Site-Level Management Representative for the Quality Management System of their assigned company Facility.
- This position may have multiple direct-reporting subordinate Managers and Supervisors in addition to having direct-reporting responsibilities for daily activities of site Quality personnel (responsibility dependent on geographic organizational structure).
- Designated Site-level Management Representative for assurance of compliance to the Quality Management System and member of the Site-Senior Management Team for the facility.
- Drive and Support Corporate QMS initiatives and continuous improvement activities.
- Ensure establishment and maintenance of site regulatory registrations (ISO 13485, FDA, etc.).
- Provide organizational Quality Leadership, coaching, mentoring and guidance to all Quality personnel as well as cross-functional teams.
- Support for integration of new manufacturing capabilities, product transfers, development programs and manufacturing customers.
- Provide Leadership and Guidance for site-level Quality functions including Documentation Control and records retention, Complaint Handling/Returns, Corrective and Preventive Actions, Training, Supplier Quality Management, Nonconforming Material Handling, and Metrology/Calibration Control Systems.
- Provide oversight and ensure compliance of Quality System support elements for the site QMS: Internal Auditing, Supplier Quality Management, Complaint Handling, Corrective and Preventive Actions, Nonconforming Materials Controls; and the tracking & reporting of associated metrics.
- Act as site-level Champion for Quality Best Practices and GDP/GMP continuous improvement efforts.
- Provide Leadership and Guidance for site-level Quality functions including incoming (Receiving & Inspection), in-process inspection, final inspection, and product release support.
- Provide Leadership and Guidance for site-level Design and Development programs, Sustained Manufacturing and Continuous Improvement/Continuation Engineering activities and initiatives.
- Provide Leadership and Guidance for Risk Management (Hazard Analysis and Assessment – Design & Process), Design and Limit Characterization, and Process Qualification (DV&V and PV).
- Oversee and coordinate site auditing activities (Customer and Customer Regulatory Agencies).
- Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
- Administration of employment practices, including, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees. Responsible to ensure these actions are performed in compliance with Federal and local laws as well as the company’s Medical policies.
- Must adhere to professional workplace attire, time, attendance and leave of absence policies.
- Other duties and responsibilities as assigned.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
REQUIRED EDUCATION & EXPERIENCE:
- Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
- Minimum of 4 years Leadership/Supervisory-level experience, with budget and decision-making authority/responsibilities.
- Minimum of 6 years’ experience in a regulated manufacturing environment.
PREFERRED QUALIFICATIONS & EXPERIENCE:
- Advanced Post-Secondary Education/Training/Certification coursework
- Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
- Class I, II and/or III Medical Device manufacturing experience.
- Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
- Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.
TECHNICAL REQUIREMENTS, SKILLS AND TRAINING:
- Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
- Successfully meet company-specific positional/functional on-the-job training requirements.
- Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
- Strong verbal and written English language communication skills
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA
Why Work Here?
Global company and has been around 15+ years that develops and markets innovative medical devices.