ACADEMIC BACKGROUND:

• BS Engineering; Mechanical, Electrical, or Industrial

EXPERIENCE:

• Minimum 5 years experience in Quality or Engineering.

• Expertise: Subject Matter Expert (SME) in product design and design controls.

• Demonstrated experience in a regulated business.

• Previous auditing experience (i.e. GAC, CAS, FDA, ISO, etc.).

• Strong knowledge of Quality Systems policies and regulations (ISO, GxP, FDA, and other key regulatory bodies) & strong background in medical device Quality Assurance & processes.

• Possesses strong understanding of the new product introduction (NPI) process.

• Ability to directly interface with governmental & independent auditors & external agencies as well as top organizational leadership successfully.

• Demonstrated experience working with Local and International Regulatory Agencies.

• Able to effectively analyze complex quality system requirements & handle multiple tasks with competing priorities.

• Ability to seek & drive alternative solutions/approaches when required.

• Strong business acumen-understands key financial metrics, understands business trends & cycles and is able to influence key business strategies & initiatives, demonstrates knowledge of key business measurements (i.e., market, products/services, suppliers, competition, performance measures) & is able to link Quality Assurance strategy to this framework.

• Responsive, reacts with appropriate urgency & professionalism.

• Change agent with energy, passion & skill to drive change.

• Strong technical aptitude (i.e. able to read & comprehend technical documentation, ability to comprehend & execute procedures, demonstrated understanding of system documentation).

• Demonstrated ability to effectively balance/prioritize issues.

• Analytical/problem solving/root-cause analysis skills.

• Effective judgment & decision making skills.

• Strong relationship building/networking/interpersonal skills.

• Excellent communication skills (written & oral).

• Integrity: Adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others.

DUTIES AND RESPONSIBILITIES:

• Provide guidance to product development teams as to the required deliverables to ensure compliance throughout product development cycle.

• Review, assess and approve product design milestones and deliverables throughout product development cycle to ensure compliance.

• Assist engineering/operational quality/compliance representatives to identify compliance risks during the product development cycle.

• Proactively assess risk, plan and execute audit deliverables.

• Communicate audit results and recommendations to senior management.

• Create and drive business wide improvement efforts to improve systemic challenges.

• Interface with Senior Management and partners during inspections, audits, investigations and report-outs as necessary.

• Educate and train engineering/operational quality/compliance representatives to ensure adoption of design control best practices.

• Travel 20-30%.

LOCATION: Various locations - nationally

CONTACT: Dan Lynch - dlynch@tsacareers.com

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