Manager, Quality

Regulatory Jobs; Town of Florida (NY); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision

Disability insurance

Life insurance

Adoption benefits

401(k) with company matching

Paid time off

80 hours holidays per year

Parental leave after one year

Job summary

Integer is seeking a Design Center Quality Team Manager to lead Quality Systems and Design Assurance, ensuring FDA and ISO compliance and meeting customer expectations.

You will mentor engineers, set goals, develop metrics, and drive design transfers in collaboration with R&D and Operations. The role offers a comprehensive benefits package and opportunities to influence quality across products.

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum 5 years in quality, design assurance, and/or design & development.
• ASQ certifications optional.

Responsibilities

• Adheres to Quality Management Systems (QMS), FDA regs, ISO 13485; uphold safety and quality requirements.
• Maintains safe and ethical business practices and adheres to Quality Policy.
• Maintains relationships with internal/external customers and vendors to resolve quality issues post-commercialization.
• Establishes and manages departmental goals, tactical plans, and metrics.
• Promotes interdepartmental coordination to ensure successful execution of the Quality Strategy.
• Manages the Design Assurance function and prioritizes QA staff.
• Maintains and improves design controls and risk management for FDA ISO compliance; enables design transfer with R&D/Operations.
• Leads test method development/validation, finished product verification, and design reviews per procedures.
• Oversees CAPA, Document Control, Internal Audit, Management Review, and Training within Quality Systems.

Skills

MiniTab

Office Suite

Problem solving

Collaboration

Team player

Education

Bachelor’s degree in engineering

Tools

CAPA software

Document Change Management

Job description

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Job Summary

The primary purpose of this position is to assume responsibility for the planning and management of a Design Center Quality Team, which includes Quality Systems and Design Assurance. This position will manage a team to meet site/organizational goals and customer expectations. Responsible for providing metrics and leadership for implementing and achieving Quality objectives.

Accountabilities & Responsibilities

• Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
• Maintains safe and ethical business practices and adheres to Integer’s Quality Policy.
• Maintains effective working relationships with internal and external customers and vendors to establish quality standards prior to design transfer, and to resolve technical and business-related quality issues post-commercialization.
• Establishes and manages departmental goals, tactical plans, and metrics.
• Promotes interdepartmental coordination and communication to ensure successful execution of the Integer Quality Strategy.
• Performs other duties as required.

  Design Assurance

• Manages and sets priorities of the Design Assurance Engineer(s) and Quality Technician(s).
• Maintains and improves the design control and risk management processes to ensure compliance to the FDA Quality System Regulation, international requirements such as ISO 13485, and to ensure the design of finished products and/or components that meet quality requirements.
• Leads the Design Assurance function to assure successful new product design transfer by collaborating with the Research and Development and Operations functions.
• Ensures the following activities occur in accordance with current procedures: test method development & validation, finished products verification, component verification, validation as part of transfers to production and design reviews.
• Responsible for the continued review of design assurance activities and processes to ensure effective design controls, risk containment, cost reduction and enhance efficiency.

  Quality Systems

• Manages and sets priorities of the Quality System Specialists
• Responsibilities over CAPA, Document Control, Internal Audit, Management Review, and Training

• Promotes and maintains alignment of Site QMS Documents with QMS Enterprise Policies.
• Participates and/or leads project teams for the implementation of enterprise and site Quality objectives.
• Organizes and provides training and mentoring for quality improvements to enhance Associate skills, increase awareness, and improve productivity.

Supervisory Duties

• Interviews, hires, and establishes training plans for direct reports. Provides leadership regarding development of individuals’ goals as well as providing mentoring of the group.
• Manages team in a manner that fosters a self-directed and collaborative team approach.
• Facilitates communication, coordination and conflict resolution within and among work groups.

Education & Experience

• Minimum Education: Bachelor’s degree in engineering or related field required.
• Minimum Experience: 5 years minimum of related experience in quality, design assurance and/or design & development.

Knowledge & Skills

• Special Skills: Collaborative, Task Driven, Team Player, MiniTab, Office Suite, problem solving techniques.
• Specialized Knowledge: Knowledge of ISO and FDA quality and system requirements, risk management, process validation. CAPA, Document Change Management, NCR, and Statistical Expertise required.
• Other: ASQ Certifications, optional.

Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.