Senior Quality Assurance Director (Medical Device Sector) - Avalign Technologies

Role Overview

The senior profile we're looking for will take charge of our Quality System, crafting strategies to ensure product quality and regulatory compliance. As our interface with governmental bodies and notified agencies, this role ensures adherence to every pertinent quality and regulatory guideline, especially at our sterile packaging facility. The appointed individual will also be the Management Representative for both the Avalign Integrated Medical Solutions in Mentor, Ohio, and Avalign Additive in Akron, Ohio.

Key Responsibilities

• Enhance and direct the site's strategic quality vision, aligning it with corporate objectives and local initiatives.
• Safeguard customer satisfaction by upholding programs and processes that conform to corporate, international (ISO), and governmental quality standards.
• Serve as the Quality Systems Management Representative at the site conducting critical liaison duties.
• Champion a robust Quality Management System, ensuring compliance and operational excellence.
• Be the front-line representative to external regulatory agencies, showcasing our commitment.
• Nurture and guide the compliance knowledge, particularly for our sterile packaging operations, ensuring they stand up to any inspection or regulation.
• Interpret and weave corporate procedures into actionable strategies ensuring holistic compliance
• Lead the quality assurance front, addressing any and all regulatory compliance challenges.
• Ensure rigorous inspection standards for raw materials and finished goods, assessing both internal and external operations.
• Maintain a productive inspection work hub within the Quality department.
• Craft and refine the site’s quality organizational structure while mentoring team members.
• Collaborate with key colleagues across functions, ensuring seamless regulatory conformity.
• Combine focus on sustaining existing quality measures with pioneering new product introduction teams.

What Defines You

• Leadership prowess in managing quality project dynamics and problem-solving initiatives.
• Finesse in communication, adapting to various levels and channels.
• Determination in setting and surpassing high-reaching goals, even amidst hurdles.
• Respectful, considerate approach to colleagues while demonstrating accountability.
• Vigilance and thoroughness, both in personal performance and team outcomes.

Qualifications & Experience

• Bachelor’s degree, ideally with a focus on engineering or the sciences.
• At least five years in a managerial capacity within quality assurance or engineering domains.
• Minimum of three years handling quality management within the medical device realm.
• Experience with medical device sterile packaging operations gives an edge.
• Unmatched leadership capabilities.

Perks of the Role

• Attractive pay alongside comprehensive benefits.
• Access to an extensive range of medical, dental, and vision plans.
• Generous leave policy with ten paid holidays annually.
• Employer-backed Basic Life and AD&D insurance.
• Employer-funded short-term and long-term disability insurance.
• Tuition reimbursement facilitation.
• Enticing 401(k) plans with a corporate match.
• Ample opportunities for internal growth within a performance-centric environment.
• Community-oriented roles encouraging active involvement and contribution.
• Additional amenities including travel resources and employee assistance programs.

Expertise Required In

• Geometric Dimensioning and Tolerancing (GD&T)
• Quality Inspection Techniques and Experience