Quality Manager- Spiddal Galway

1 month ago

Spiddal, Ireland Integer Holdings Corporation 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. 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.

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

  • NPI Engineer II- Spiddal Galway

    1 month ago

    Spiddal, Ireland Integer Holdings Corporation 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...

  • Senior Financial Analyst- Spiddal Galway

    1 week ago

    Spiddal, Ireland Integer Holdings Corporation 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...

  • General Operator

    1 week ago

    Spiddal, Ireland Integer Holdings Corporation Full time

    About the Role : As a Production Operator you will be responsible for the manufacture, product-inspection, testing, labelling & packaging of Class II / III medical device implant products within a Clean room environment. All operations are conducted under stringent quality control systems to GMP standards. The successful candidate will work as part of...

  • R&D Engineer I

    1 week ago

    Spiddal, Ireland Integer Holdings Corporation Full time

    About the Role : An R&D Engineer is required to support Aran Biomedical’s world-class Biomaterial Design & Development team through a phase of rapid expansion and growth due to new business activities.  This position will report to the Engineering and Design Services Manager and will be responsible for supporting all aspects of the Device...

  • Quality Technician II

    1 month ago

    Spiddal, Ireland Freudenberg Full time

    Empowering people, creating technology. Responsibilities: Make product dispositions as and when required. Update documentation such as specifications and visual standards to better define the quality characteristic being dispositioned. Prepare and update documentation such as Work Instructions, Product Routings (CHR’s), Visual Standards etc. as...

  • Operational Excellence Manager

    1 month ago

    Spiddal, Ireland Freudenberg Full time

    Working at Freudenberg: We will wow your world! Responsibilities: Lead all aspects of the Operational Excellence (GROWTTH®) program. Provide leadership and foster cross-functional teamwork to exceed Operational Excellence targets. Lean the annual cost reduction project (IMPACT), to deliver planned year-on-year saving. Lead GROWTTH® events...

  • Moulding Engineer

    1 month ago

    Spiddal, Ireland Freudenberg Full time

    Empowering people, creating technology. Responsibilities: Process Introduction of New Tools; Tool trials at tool makers and in-house, tool set-up, qualification runs and handover to production. Assist with the design and debugging of new systems, tooling and automation. Completion of IQ, OQ, PQ validation reports. Complete product validations...

  • Senior Moulding Engineer

    1 month ago

    Spiddal, Ireland Freudenberg Full time

    Empowering people, creating technology. Responsibilities: Lead a dedicated group of Engineers and Technicians within the Injection Moulding department, Ensure engineers are fully integrated within the overall production support team. Plan and implement training and development plans with subordinates. Coach and mentor team members. Set...

  • Senior Manufacturing Engineer

    4 weeks ago

    Spiddal, Ireland Freudenberg Full time

    Working at Freudenberg: We will wow your world! Responsibilities: Lead a dedicated group of Engineers and Technicians within the Manufacturing Group. Ensure engineers are fully integrated within the overall production support team. Plan and implement training and development plans with subordinates. Coach and mentor team members. Set...

  • Senior Buyer Planner

    1 month ago

    Spiddal, Ireland Freudenberg Full time

    Empowering people, creating technology. Responsibilities: Inventory Management Manage the MRP element of the S&OP cycle. This includes the management of purchase orders, delivery schedules, expedites and Kanban maintenance to ensure availability of material to meet customer demand while adhering to agreed inventory limits. Implementation and...