Manager, Quality

Integer Holdings Corporation; Town of Florida (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Integer Holdings Corporation seeks a Design Center Quality Leader to manage the Quality Systems and Design Assurance teams. You will set priorities, drive design controls, and ensure compliance with FDA QSR and ISO 13485.

You will lead the Transfer of designs to production, develop test methods, validation, and CAPA programs while guiding cross-functional teams in R&D and Operations.

Qualifications

• Bachelor’s degree in engineering or related field required.
• Minimum of 5 years of related experience in quality, design assurance and/or design & development.
• Knowledge of ISO 13485, FDA QSR, CAPA, risk management, and process validation preferred.

Responsibilities

• Lead Design Center Quality Team and manage Design Assurance Engineer(s) and Quality Technician(s).
• Maintain and improve design control and risk management processes to ensure compliance with FDA and ISO requirements.
• Provide metrics and leadership for implementing and achieving quality objectives.
• Promote interdepartmental coordination to execute the quality strategy and support design transfers.

Skills

Collaborative

Team Player

Problem Solving

Quality mindset

Documentation

Education

Bachelor’s degree in engineering or related field

5 years minimum experience in quality, design assurance or design & development

Tools

Minitab

MS Office

Job description

Values

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.

Special Skills

Special Skills: Collaborative, Task Driven, Team Player, MiniTab, Office Suite, problem solving techniques.

Specialized Knowledge

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

Other: ASQ Certifications, optional.

Our total rewards program

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.

Equal Opportunity Employer

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

Equal Opportunity Statement

Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active-duty wartime veteran, campaign badge veteran, referred to collectively as "Protected Veterans." It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment. Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons. If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at [phone] or via [e-mail] so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening. This phone number and email address is strictly for the purpose of making a request for an accommodation. Status updates on your application cannot be provided to you through this phone extension or email. For status updates, please log in to https://integer.wd1.myworkdayjobs.com/en-US/External/login

Company Information

Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company's brands include Greatbatch Medical® and Lake Region Medical®.

Additional Information

Additional information is available at www.integer.net.

Remote Eligibility

For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.

Privacy Statement

To review the Integer Applicant Global Privacy Statement, please click link below for your preferred language: English| Spanish| Malay| Chinese Thanks for your interest in working on our team!!