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Manager, Design Quality Assurance

Aesculap Implant Systems

This is a Contract position in Lehigh County, PA posted April 24, 2019.

Position Summary: The Manager of Design Quality Assurance leads a team of Quality Engineers and Technicians in direct support of product development; responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management in the development process.

He/She is a key partner to the Research & Development, Regulatory and Marketing teams in achieving new product development and commercialization.

He/She is Quality Team lead for all quality functions that contribute to the product development process and global regulatory requirements while ensuring a focus on patient safety and product performance.

This manager owns and manages quality discrepancies during the design and development process, and develops scope and disposition, as well as assigning corrective actions for prevention of future discrepancies.

May serve as liaison between the company and the Food and Drug Administration.

Responsibilities: Essential Duties Principal Duties & Authorities: Leads quality team on product development projects.

Leads quality team on functional deliverables and ensures product technical development.

Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance; key partner in all department goals and objectives.

Develops and implements quality strategies to attain quality goals.

Provides guidance and training to staff, assists subordinates in attaining career goals, to include motivating individuals in achieve results.

Recruits and maintains a high qualified staff.

Assist in Development of department budget and monitors spending.

Determines appropriate staff levels and schedules by working with key partners to understand priorities.

Maintains and enhances cross-functional team relationships.

Provides guidance regarding technical strategies and approaches for product quality assurance; works cross-functionally in identifying and resolving technical issues.

Lead a team of employees in the achievement of organizational goals.

Coach, direct, and develop a high performing team.

Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

Monitor and ensure compliance with company policies, procedures and regulatory requirements.

Perform all duties in a manner consistent with cGMP and Company’s SOPs.

Must comply with applicable ISO and FDA regulations as stated in Quality Manual.

Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.

Demonstrate behavior consistent with the company’s Code of Ethics and Conduct.

Must embody the Company’s Vision, Mission and Values.

Other duties may be assigned Secondary or peripheral job functions: Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others.

Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes.

Demonstrate behaviors that drive efficiency by understanding and improving processes as well as sharing best practices.

Manager Responsibilities: Provide direction and coordinate daily activities of quality personnel (such as Quality Engineers and Quality Technicians) taking a lead role in accordance with company policies.

Responsibilities may include interviewing, training, assigning and directing work, appraising employee performance.

Expertise: Knowledge & Skills Language Skills : Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

Ability to write routine reports and correspondence.

Ability to speak effectively before groups of customers or employees of organization.

Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals.

Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

Ability to deal with problems involving several concrete variables in standardized situations.

Qualifications xpertise: Qualifications
– Experience/Training/Education/Etc Required: Bachelor of Science degree plus 7-9 years of related work experience.

5 years of direct or cross functional project team management experience preferred.

Technical background, 4-year engineering degree preferred with a passion for technology development and continuous improvement.

Medical Device or regulated industry experience required.

Functional understanding of Good Manufacturing Practice (GMP) QSR 820, FDA Quality System Regulations (QSR) & ISO13485 Quality Management Systems.

Excellent communication skills, over the telephone, in person, and in writing.

Knowledge of 21 CFR Part 820, Quality Systems Regulations.

High level of computer proficiency is required.

Knowledge of MiniTab preferred.

Preferred: Certified Quality Auditor.

Experience leading technical teams.

Advanced degree in a technical field or business preferred.

Regulatory compliance experience in the areas of medical devices and analytical methodology.

Desired: N/A While performing the duties of this job, the employee is regularly required to sit and talk or hear.

The employee frequently is required to use hands to handle or feel and reach with hands and arms.

The employee is occasionally required to stand and walk.

The employee must occasionally lift and/or move up to 30 pounds.

Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.

To learn more about B.

Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at Through its “Sharing Expertise®” initiative, B.

Braun promotes best practices for continuous improvement of healthcare products and services.

Other Responsibilities: Other Duties The preceding functions have been provided as examples of the types of work performed by employees assigned to this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed in this description are representative of the knowledge, skill, and/or ability required.

Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.