Quality Manager

JOB DESCRIPTION:
The successful candidate will manage and monitor performance of all aspects of quality assurance and quality control.
The ideal candidate will demonstrate a firm understanding of quality management systems specifically focused in the medical device field. Expert understanding of the QSR, ISO 9001, ISO 13485, control plans, and ISO 14971 are required. Additionally, this candidate will have working knowledge of GLP, sterilization equipment, methods and procedures, fundamental engineering principles and their application in real-world scenarios. This candidate will prefer a hands-on approach, and will thrive in a fast-paced, deadline-sensitive environment. The individual must be able to manage multiple simultaneous projects, and be self-motivated and able to motivate others in a creative, collegial atmosphere.
This individual will be responsible for implementing, managing and developing all aspects of the company’s quality system, as well as for handling all internal issues related to quality. These responsibilities will include people management , complaint handling, CAPA system management, document control , quality activities associated with change control, quality activities associated with design control, internal and external audit, quality support for supplier development and controls , process development and validation support , technical and statistical support to the quality control group, and key aspects of continuous improvement activities .
This individual will be expected to work closely with senior management and partner with other functional leaders to ensure compliance with company quality policies, procedures and medical device regulations. This individual may serve as the Management Representative as required.
Additional responsibilities will include setting standards and best practices for quality of work and commitment to excellence, identifying resource needs, review of team members work products, technical mentoring of team members, and providing critical inputs into and leading aspects of the company's quality system plan and associated objectives.
This individual will work closely with other departments including quality, engineering, manufacturing, purchasing, human resources, customers, sales, consultants, regulators and external suppliers.
Additional responsibilities of this position include:

• Communicate effectively, both verbally and in writing, internally across departments and with external suppliers, regulators and customers.
• Develop and cultivate long-term relationships with customers providing ongoing quality assurance support.
• Work closely with customers to support audits and quality requirements identified through the product development process and in quality and supply agreements.
• Ensure all designs function as required and comply with the Company’s quality assurance requirements as well as applicable regulatory requirements.
• Establish and meet schedules and budgets.
• Contribute to an environment of innovation and function as a source for creative energy

TRAINING REQUIREMENTS:

The candidate must have a track record of successful quality management system development and implementation. This individual will have a demonstrated track record of coordination of multiple simultaneous projects of varying levels of complexity and achieving results through others in a leadership role.

The candidate must have excellent interpersonal, communication and influencing skills as well as experience working collaboratively internally with sales, engineering and manufacturing and externally with regulators and customers. The candidate must be able to communicate both orally and in writing with customers at all levels, and articulate customer needs accurately to internal departments.

The candidate must have demonstrated experience in quality assurance and quality control roles specifically as related to sterilization cases and trays for orthopedic industry. It is preferred that the individual also have demonstrated experience in all aspects of quality control and quality assurance as described above.

The candidate must be an expert in the medical devices regulatory environment and associated quality system requirements.
It is expected that this candidate will be a self-motivated, operationally minded leader who thrives in a non-bureaucratic, hands-on, entrepreneurial environment and can provide the leadership needed to steer the quality team forward.

The candidate should be experienced in:

• People management, recruiting, performance assessment, training, coaching and development.
• Implementation and development of a medical device quality management system.
• Supplier assessment, development and controls.
• Design control, document control and change control.
• Process validation.
• Gage R&R, sampling plans and associated statistical methods, and mechanical inspection methods.
• Chemical and mechanical characterization of products, materials, and processes.
• Test method development and qualification.
• Demonstrated technical competence in and experience in at least one of the following manufacturing techniques: sheet metal working, machining of metals and plastics, vacuum thermoforming and/or injection molding.
• Familiarity with reading mechanical prints and GD&T.
• Familiarity with CE/EN requirements and regulatory filings in the US and abroad.
• Familiarity with mechanical design and product development processes.
• A demonstrated ability to innovate, strive for continuous improvement and provide creative leadership.

EDUCATION:

• A minimum of a Bachelor’s degree in Engineering or a relevant scientific discipline with a focus 7 years of relevant experience, or a Master's degree in the same with 5 years of experience is required.
• Appropriate certifications may include Certified Quality Engineer, Certified Quality Auditor, and Certified Lead Auditor.
• Six Sigma Green Belt is desirable.
• Training in Lean and 5S are desirable.

EXPERIENCE:

• Minimum of 5 years’ experience in the medical device field in roles such as quality engineer, quality control supervisor, auditor, quality assurance, quality manager.
• Familiarity with machining, metal finishing, sheet metal fabrication and assembly processes.
• Familiarity with the orthopedic industry.

Pay: $110,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $110,000 - $130,000