Senior Manager, Complaints - REMOTE
Class III Global Medical Device Manufacturer
Opportunity to oversee global team
About Our Client
Our latest client is a global medical device manufacturer that has been in business for over 30 years. They have a global presence and operate have continued to growth through COVID. Located in the northern suburbs, their Illinois location has over 300 employees. They seek a Senior Manager of Global Compliance to oversee a team of 6 including Senior Analysts, Analysts and Engineers. This role will report to the Director of Global Compliance.
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.
The Senior Manager will be responsible for the following;
- Maintains a key role in continually examining current GCM complaint handling processes to ensure day to day operations meet regulatory requirements and guidance's.
- Demonstrates experience working in a cross-functional environment with medical, engineering, risk management, and regulatory professionals.
- Serve as a primary point of contact from GCM Managers for issue escalation for issues identified by vendors (outsourcing).
- Ensure CAPA program effectiveness by maintaining the CAPA portfolio, governance board, program metrics etc.
- Support/Lead internal and external audits.
- Support Customer Advocacy and engage appropriate subject matter experts (departments) into a resolution team, which will often require direct engagement with the customer.
The Successful Applicant
- Bachelor's Degree in a Sciences, Engineering or related discipline required, Master's degree preferred; or equivalent combination of education, training and experience.
- 10 years previous experience as a Quality professional supporting product development, product manufacturing, production and process control activities and Quality Systems support and maintenance required
- Minimum of 3 years' experience managing and leading a team of professionals required.
- Extensive experience and knowledge of FDA's Quality System Regulations, ISO 13485 and Medical Device Regulation required. Experience with other regulations is desired (Canada, Europe.)
- Proficient with computers and software such as Outlook, Word, Excel, PowerPoint, WebEx, Visio, TrackWise Digital
- ASQ Certifications are desirable (CQM, CQA, CQE etc.).
- Six Sigma DMAIC experience and certification are highly desirable
What's on Offer
- Competitive base salary between $110,000-$130,000, depending on experience and skills
- Yearly bonus, circa 10% (Paid out consistenly over the last 5 years)
- 401k match of 5%
- Benefits including, medical, dental, life, disability and tuition reimbursement
- 20 PTO Days + 9 holidays
- Remote flexibility through summers, long term flexibility