Quality Manager - Global Medical Device Manufacturer
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
Urgently seeking an experienced Quality Manager to come into a thriving and well-established Medical Device Manufacturer. My client is interested in hiring someone with some experience specifically as a Quality Manager in a relevant industry and they look to provide appropriate training and ultimately grow this person within the business over the next 5-10 years.
Our client is a medical device manufacturer located in the Wheeling area. With over 15 locations throughout the US and 5000 employees, they have continued to grow out new product lines. They seek a Quality Manager to join their Quality team and report to the Director of Quality. Their clients include well known OEMs, such as Stryker and Medtronic. This role will be a highly responsible, independent and managerial position responsible for all aspects of the quality systems process
The Quality Manager will be responsible for;
- Document and data change control, training, corrective and preventive action, discrepancy handling, product release, environmental monitoring, and complaint handling.
- Provide consultation to all departments on application of quality and regulatory requirements.
- Develop and maintain quality system procedures for quality and regulatory department responsibilities.
- Lead quality assurance and regulatory affairs functional review and approval of quality system documentation.
- Manage quality engineering support function; indirect support to quality inspection teams who report to quality engineering.
- Work in a close, collaborative fashion with management in the pursuit of adherence to documented processes and the development of key performance indicators.
- Interact with customers and suppliers on all quality matters while building and maintaining strong relationships.
- Directs the selection, training, and development of personnel within the limits of company administration policy.
- Coach, mentor, develop, direct, train, and evaluate the work of quality improvement personnel.
- Maintain a robust Quality Management System that meets all FDA, ISO 13485 and customer requirements.
- Ensure customer satisfaction with product quality.
- Receive and provide communications and related materials and reports regarding parts revisions, parts on hold, questions on dimensions, parts rejections, parts changes, qualifications, validations, internal audit data, and other quality-related information the customer requires.
- Receive, interpret, and implement corrective action procedures for product quality that the customer requires.
- Bachelor's Degree (Engineering related), Master's Degree preferred
- 8+ years of experience in a manufacturing environment, specifically in metal working or medical device manufacturing preferred
- Project Management and Lean Manufacturing experience
- Good knowledge of statistical toolsand appropriate use of Design of Experiments (DOE) when developing recommendations
- Excellent communication and interpersonal skills
- Working knowledge of ISO 9001:2015, ISO 13485:2015, 21 CFR and cGMPs
- Competitive base salary between $100,000-$150,000 depending on experience and skills
- Bonus opportunity up to 6%
- Comprehensive benefits package including Medical, Dental and Vision
- Medical/Prescription Drug Coverage - 3 Blue Cross Option (2 PPOs, 1 HDHP)
- Health Savings Account and Flexible Spending Accounts
- Dental Coverage - 2 MetLife Options
- Life and AD&D Coverage
- Short-term disabiltiy coverage
- 15 PTO Days + 10 holidays
- 401(k) with 3% company match