Sr. Quality and Regulatory Affairs Manager

About the role

The Sr. Quality and Regulatory Manager will provide overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. Objectives involve ensuring patient and employee safety, achieving customer quality requirements, creating, monitoring, and improving quality systems/programs, reducing quality costs, and maintaining compliance within FDA and ISO regulations for over $40 million in annual sales. This role requires accomplishing these goals within Tecomet’s principles of continuous improvement, customer-driven innovation, and a win-first culture while meeting company financial and performance metrics.

Responsibilities

• Oversee and implement an advanced level of world-class quality systems for planning, design of experiments (DOE), ISO 13485, quality function development (QFD), and design for world-class manufacturability.
• Take a leadership role as a Sr. Manager and mentor supporting functional team members.
• Integrate the quality function with manufacturing as a value-added (real-time) support function, optimizing the continuous quality improvement process while reducing cost and improving customer relationships.
• Design and facilitate the development of quality systems for a highly regulated medical device industry to achieve customer satisfaction, increase productivity, and maximize profit margins. The objective is to devise systems that facilitate good products fast without compromise.
• Assure Tecomet conducts business within compliance to regulations as cost-effectively and efficiently as possible.
• Provide organizational assessments to upper management.
• Enhance one-company systems interface capabilities to optimize harmonized systems improvements by deploying best practices from worldwide teams.
• Ensure the quality systems focus remains on continual quality improvement, aligned with internal and external customer expectations, to achieve an error-free (flawless) process delivering products on time with world-class quality standards.
• Ensure improvement-related decisions are based on factual and meaningful data, reducing waste and expediting recognition of favorable results.
• Lead responsibility for promoting and developing Tecomet’s Environment Management System; Worldwide Quality Management Systems Software implementation/validation and harmonization (ETQ); New Product Development; and Worldwide Supplier Quality Systems.
• Perform other duties or special projects as required or assigned by a supervisor.

Requirements

• Bachelor of Science in Engineering.
• 5+ years of Quality Engineering experience within a manufacturing environment.
• 2+ years of experience working within a regulated environment is preferred.
• 3+ years working directly with New Product Development and/or related launches.

Skills

• Strong organizational skills.
• Strong people and leadership skills.
• Diplomacy, motivation, teaching/coaching/mentoring.
• Verbal and written communication and listening skills.
• Highly proficient in Microsoft Office.
• Problem-solving and evaluation.
• Process improvement and project management.
• Knowledge of ISO 13485/EN46001, ISO 14001, federal and state laws and regulations, international quality and environmental standards.
• Strong auditing background.
• Ability to speak in front of people in a variety of settings.
• Flexibility and adaptability to changes in the marketplace.
• Ability to create and manage high-performing work teams.
• Professional and courteous interface with customers/public/internal staff.
• Prioritization of work to meet goals and objectives set for the company.
• Consistent and professional decision-making.

Benefits

• Competitive pay and benefit packages.
• Health benefits start on day one.
• 401k available with company match.
• 9 paid holidays with 2 floating holidays.
• Paid time off (PTO) offered.

Physical Demands

The work environment is typical of similar jobs in comparable organizations. While performing the duties of this job, the employee could be required to stand, walk frequently, use hands to finger, handle, or feel, reach with hands and arms, and talk or hear. The employee could be required to sit, climb or balance, stoop, kneel, crouch, or crawl. The employee could occasionally lift and/or move up to 50 pounds. Specific vision abilities required include close vision, distance vision, peripheral vision, and the ability to adjust focus.