Senior Manager, Quality and Regulatory

2 weeks ago

Palm Harbor, United States Integer Holdings Full time

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

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.
  • Acts as site Management Representative.
  • Creates a strong and accountable QA/RA team through the coaching and leading of supervisory staff, and the hiring and planned development of team members. Manages subordinates in a manner that fosters a self-directed team approach.
  • Establishes and manages departmental strategic, tactical plans, and metrics. Additionally, this function establishes and manages budget to support quality function and Category team requirements.
  • Establishes strong peer partnerships and promotes interdepartmental coordination and communication within the matrix organization to drive, support, and ensure successful execution of site strategic objectives.
  • Acts as the primary site representative with all customers for operations quality. Maintains effective working relationships with internal and external customers and vendors to establish quality standards prior to initial production, and to resolve technical and business-related quality issues post-production.
  • Collaborates with all stakeholders to ensure regulatory requirements are met and risk management considerations are addressed in product development plans.
  • Develops, maintains and improves the quality management system in collaboration with global quality systems to ensure compliance to the FDA Quality System Regulation, international requirements such as ISO 13485, and ensures production of finished products meet quality requirements. Interprets and applies new regulations standards and supports process owner on implementation.
  • Develops and maintains auditing processes, procedures and activities to maintain compliance with quality standards, customer requirements, and a state of audit readiness at the site.
  • Manages the preparation of quality control instructions and procedures, and ensures training is executed.
  • Manages the quality engineering function to meet goals and customer expectations.
  • Leads and manages the site quality and design assurance functions to assure successful new product design transfer and post-market surveillance by collaborating with the Operations, R&D, NPI, Commercial, and Regulatory functions.
  • Reports to senior management on the site progress toward quality targets.
  • Directs the continued review of quality activities and the creation of new or revised processes to ensure quality improvements reduce costs and enhance efficiency. Provides training and mentoring in Quality improvements techniques to upgrade Associate skills, increase awareness, and improve productivity.
  • Incorporates Lean initiatives in support of overall production optimization and Quality initiatives. Ensures Associates participate in continuous improvement efforts and are trained to comply with quality system requirements.
  • Investigates, identifies and executes cost effective solutions to various technically related non-conformance problems so that the customers' needs are satisfied.
  • Manages and develops regulatory and clinical affairs to successfully liaison with external regulatory, legal, clinical and physician contacts in support of new products, regulatory strategy, post market surveillance, clinical evaluation, and field actions.
  • Responsible for overseeing aspects of regulatory support on new product development, post market surveillance, and regulatory reporting requirements for applicable products. Provides regulatory guidance with respect to interactions with Notified Bodies to assure compliance with applicable requirements.
  • Performs other duties as required.

Education & Experience:

  • Minimum Education: Bachelor's degree in Engineering, Math or Statistics. Master's degree preferred. ASQ certification preferred. Regulatory Affairs Professional Society (RAPS) medical device certification preferred.
  • Minimum Experience: 10-12 years of experience in quality or technical functions within the medical device industry, with 3-5 years in managerial experience.

Knowledge & Skills:

  • Special Skills:
    • Excellent written and oral communication skills; ability to communicate effectively to Executive level staff; experience with verbal and written communication to FDA and to customers; strong technical writing skills.
    • Project management, team development, and management skills.
    • Strong leadership skills with demonstrated ability to drive positive results.
    • Ability to work through difficult issues with suppliers, customers and regulatory bodies. Ability to assimilate and analyze information efficiently and apply critical evaluations.
  • Specialized Knowledge:
    • Prior experience as a Quality Management Representative.
    • Understanding of risk management issues associated with regulated product.
    • Experience with Class III/Implantable devices preferred.
    • Experience with new product development launch processes preferred.
    • Knowledge of applicable laws which regulate medical device manufacturers; experience with ISO, GMP, GDP, and related quality systems.
    • Experience with management of post market surveillance activities.
  • Other: Working knowledge of Microsoft Office; Visio and Minitab preferred. Must be in compliance with PRRC (Person Responsible for Regulatory Compliance) job specifications for this role (if applicable)d

U.S. Applicants: EOE/AA Disability/Veteran

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