General Summary of the Position

The Quality Manager is responsible for the oversight of Quality Control, Quality Engineering and Supplier Quality functions. This role will have Quality Control Inspectors and Quality Engineers reporting to them and the role will be responsible for the development, supervision, coordination, and maintenance of the Quality Control and Quality Engineering Program. Through established standards and customer specific requirements, this role is responsible for meeting company objectives, facilitating continuous improvement, and achieving total customer satisfaction. The priority areas of focus include supplier quality, measurement and analysis of materials, components and finished goods, internal process quality, internal/external customer experience, sterilization, risk management and maintaining the quality management system State of the Art. This position serves as an engaged and trusted quality expert in the organization. Success in this role is measured by detection and handling of failures through the optimization of quality control routines and management of measurement and testing equipment. Key deliverables to ensure success are listed below:



Essential Functions

(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills, and other characteristics. This list of tasks is not a comprehensive listing of all functions and tasks performed by this position. It does not imply that this position performs all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)

Leadership

• Ensures adequate personnel coverage for areas of responsibility and ensures employees are trained and competent to perform assigned tasks.
• Develops and mentors direct and indirect reports, which may include the utilization of external
  resources and training programs.
• Assigns work responsibilities to direct reports and monitors employee performance to ensure
  compliance with policies and enhance productivity/efficiency.
• Facilitate and lead cross-departmental meetings, the voice of Quality and technical expert in areas of responsibility on cross-functional teams.
• Quality Liaison with suppliers, vendors and contract manufacturers.
• Presents key performance indicators through periodic regulatory communication and management review.

Risk Management

• Manages and monitors Risk management program per ISO 14971 to ensure adherence to established procedures and regulatory standards.

Supplier Quality

• Manages and monitors supplier quality programs, including supplier qualifications, supplier ratings and supplier audits to ensure adherence to established procedures and regulatory standards.

Sterilization

• Manages and monitors sterilization program, including management of sterilization
  facilities (gamma and EO) and product families (validations, testing, requalification, and product
  adoptions).

Software

• Manages and monitors Software validation program, including assessment of new and existing software and managing the validation/revalidation of software utilized in the QMS.

Quality Control

• Oversee the development of product specifications, inspection plans, test methods to align with
  current procedural requirements, contract manufacturing requirements including ANSI sampling
  methodology.
• Oversee the development of laboratory test procedures, perform and/or oversee test method validation and execution of testing.
• Manages the equipment calibration, maintenance and preventative maintenance
  program. 
• Makes acceptance/rejection decisions on products and materials being inspected, initiates MRBs as appropriate and provides leadership to the quality control team on disposition decisions.
• Has authority to temporarily stop processes to correct quality, safety or environmental problems,
  identify and place suspect product on quality hold, and to promptly notify management when
  processes become noncompliant.
  

Quality Management System

•  Resolves CAPAs within required timelines in areas of responsibility.

• Monitors quality assurance objectives and key performance indicators complementary to company policies and goals and consistently strives to improve metrics.
• Provides support for process-related corrective action implementation, quality-related production
  documentation, studies and activities necessary to increase control and lower cost of poor quality.
• Support customer complaint investigations, by performing root cause analysis through use of various quality tools, sample reviews and analysis of measurement testing data and technical expertise.
• Oversee maintenance of product families as state of the art through the application of new and
  revised technical standards.
• Review and approve design control, manufacturing, quality, engineering, and validation/ qualification documents for conformance to departmental procedures and risk management.
• Review product labels/labeling, ensuring technical accuracy, alignment with the risk profile of the
  device, and compliance with US and international regulatory requirements and standards.
• Works closely with Quality Management regarding planning and coordination of all activities that
  impact or could potentially impact the Quality Management System.
• Provide technical documentation and support to internal and external customers, including but not limited to RoHS/REACH, hazardous materials, MSDS, and regulatory technical summaries.
• Understand quality system requirements of customers, FDA, ISO 13485, MDSAP, and other regulatory agencies, and use quality tools to improve processes and products within those standards.

General

• Works closely with onsite personnel therefore must be onsite at facility a minimum of 3 days a week.
• 20% travel required to perform supplier audits.

Knowledge, Skills, and Abilities

• Strong knowledge of ISO 13485, 21 CFR 820 and MDSAP
• Strong knowledge of Engineering Change Control procedures and practices
• Strong knowledge of Document Change Control procedures and practices
• Ability to self-prioritize, remain self-motivated and drive favorable KPIs
• Working knowledge of statistics, ANSI sampling methodology, quality tools and root cause analysis
• Ability to manage many projects while maintaining accuracy and sense of urgency.
• Strong aptitude for reading, understanding, communicating, and applying complex and detailed
  guidelines and requirements from multiple agencies in multiple countries.
• Unwavering attention to detail.
• Ability to work and influence people in various levels, departments and functions in the company
• Strong verbal and written communication skills Ability to maintain a professional, courteous, and
  positive demeanor in all situations.

Education, Training, and Experience

• Bachelors degree in scientific/technical field and 5 years experience in medical device industry.
  Experience should demonstrate a progression in scope of responsibility.
  or
• Associates degree in scientific/technical field and 8 years experience in medical device industry. Experience should demonstrate a progression in scope of responsibility.

Preferred Experience:

• Proficient with ERP (Syspro), eQMS (Unipoint), minitab, microsoft office and equipment software.
• Certified Quality Engineer
• Certified Supplier Quality
• Certified Quality Auditor
• Certified Project Manager

This job description is not designed to cover or contain a comprehensive listing of activities, duties or
responsibilities that are required of the employee. Additional responsibilities and duties will be required
depending on a variety of factors.