What are the responsibilities and job description for the Sr. Manager- Quality position at JJ SONIK?
Sr. Manager- Quality
Location: East Coast (Relocation Required and Paid For)
Are you a quality-focused leader passionate about improving product performance and ensuring exceptional customer satisfaction? We're seeking a Sr. Manager of Quality Engineering to lead initiatives that enhance product quality, resolve customer issues, and elevate operational standards. This role is based on the East Coast and will require relocation.
Key Responsibilities
As a Sr. Manager, you will oversee post-market quality operations, including:
- Leading product quality evaluations and root cause investigations based on customer feedback and field reports.
- Developing and monitoring performance metrics to ensure alignment with quality standards and identifying areas for improvement.
- Building and managing a customer-facing quality team to collaborate with sales and service teams, participate in field visits, and address quality escalations.
- Driving swift resolution of product quality issues, including recalls, adverse event reporting, and effective communication with regulatory bodies.
- Collaborating with cross-functional teams such as R&D, Manufacturing, and Supplier Quality to implement quality improvements and expedite solutions.
- Conducting health risk assessments for complaints, CAPAs, and field actions while ensuring compliance with industry regulations.
- Analyzing investigation findings and presenting actionable trends and recommendations to leadership.
- Providing input to new product development teams to ensure quality considerations are built into product design.
Qualifications and Expertise Required
- Experience: 7 years in a regulated industry (medical device preferred), with proven management experience.
- Education: Bachelor’s degree in an engineering or scientific discipline (e.g., Mechanical, Electrical, or equivalent).
- Knowledge:
- Familiarity with regulatory standards such as 21 CFR Part 820, ISO 13485:2016, EU Medical Device Regulation, and Canadian MDR.
- Expertise in complaint processing, CAPA management, and statistical analysis.
- Experience in facilitating cross-functional collaboration and managing post-market quality data.
Leadership: Skilled in developing and managing high-performing teams, with a strong focus on engagement and professional development.
