Job Description

The Quality Manager is responsible for oversight and integrity of the Quality System and establishes product quality and compliance strategies. The role also acts as a liaison between the company and various governmental agencies and notified bodies to assure compliance to all quality and regulatory standards. This role will oversee the overall compliance of the medical device sterile packaging area at the site. The role will act as the Management Representative for the Avalign Integrated Medical Solutions located in Mentor, Ohio and Avalign Additive located in Akron, Ohio.

**What You'll Do:

**¨NBSP;

• Provides vision and leadership for quality for the site by enforcing Corporate quality objectives and linking those objectives to site activities

• Maintains quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established company, international (ISO), and governmental regulatory standards and agency guidelines, and to ensure customer satisfaction

• Acts as the Quality Systems Management Representative for the site

• Maintains compliance and effectiveness of the Quality Management System

• Represents the business/site to outside regulatory bodies

• Provides leadership and compliance knowledge to ensure the sterile packaging operations, and operations in conjunction with the sterile packaging area, are properly validated, maintained, and function to all required regulatory standards and internal procedures.

• Provides expertise and guidance in interpreting Corporate procedures, governmental regulations, and internal policies to assure compliance and drives implementation for the site

• Manages quality assurance efforts and is responsible for all regulatory compliance issues

• Maintains quality system through establishing a system for internal and external inspection of raw materials and finished items purchased and production operations and processes

• Ensures adequate operation of the Quality department inspection work center.

• Determines and establishes assigned quality organizational structure and supervisory relationships. Coaches, develops, and mentors employees in work group

• Collaborates with cross-functional colleagues to ensure achievement of standards and regulations

• Manages both sustaining and new product introduction quality teams

• Other duties may be assigned.

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**What You Won’t Do:

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• Feel stuck – we offer great opportunities to advance and learn

• Get bored – we make custom products, so no day is the same

• Feel like a number – we’re a close-knit bunch and always have each other’s backs

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**Who You Are:

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• Ability to lead quality project management and present problem resolution

• Ability to listen effectively and utilize various modes to communicate with employees at all levels

• Possesses a proficient written and technical communication skillset

• Sets and achieves challenging goals and is persistent to overcome obstacles.

• Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions and follows through on commitments.

• Demonstrates accuracy and thoroughness to improve and promote quality; Applies feedback to improve performance; and monitors own work to ensure quality.

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**What You'll Need:

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• Bachelor’s degree, engineering or science preferred

• Five (5) or more years management experience in quality assurance and/or engineering discipline.

• Minimum of three (3) years’ experience in a medical device industry in quality management

• Experience with a medical device sterile packaging operation preferred

• Position requires excellent leadership skills.

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**What You’ll Enjoy:

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• Competitive compensation and benefits package

• Comprehensive medical, dental, and vision insurance

• Paid vacation and 10 observed paid holidays per year

• Employer funded Basic Life and AD&D insurance

• Employer funded STD and LTD insurance

• Tuition reimbursement

• Great 401(k) with company match

• Generous employee referral bonus program

• Working for a thriving, performance-based company that values promoting from within and career advancement

• Temperature controlled environment

• Community involvement investing and giving back to the community

• Additional free resources such as travel assistance, EAP, etc.

You should be proficient in:

• GD&T
• Quality Inspection Experience