Senior Manager, Quality Assurance and Regulatory Affairs
Company: Integer Holdings Corporation
Posted on: May 6, 2021
The primary purpose of this position is to assure quality and
complaint manufacturing of medical devices and components by
providing oversight of applicable QA/RA processes, establishment of
technical direction, and the management of a team of QA/RA
Engineers, Specialists, and Technicians. This position serves as
the site Management Representative, accountable for the
establishment and execution of a quality management system as
defined by Integer's Quality policies, FDA QSR, ISO 13485, and the
Medical Device Directives. This position will lead and supports
quality improvement across the organization.
- 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
- 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
- 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
- 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
- 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
- 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: o 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.
- o Project management, team development, and management
- o Strong leadership skills with demonstrated ability to drive
- o 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: o Experience with management of post
market surveillance activities.o Prior experience as a Quality
Management Representative. o Understanding of risk management
issues associated with regulated product. o Experience with Class
III/Implantable devices preferred. o Experience with new product
development launch processes preferred. o Knowledge of applicable
laws which regulate medical device manufacturers; experience with
ISO, GMP, GDP, and related quality systems.
- Other: Working knowledge of Microsoft Office; Visio and Minitab
Keywords: Integer Holdings Corporation, Minneapolis , Senior Manager, Quality Assurance and Regulatory Affairs, Executive , Minneapolis, Minnesota
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