JOB SUMMARY
Responsible for managing the quality and compliance for applicable products and processes for assigned department(s).Adapt departmental plans and priorities to address resource and operational challenges.
MAJOR RESPONSIBILITIES
Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product.
Acts as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.
Manage complaints and develop new approaches to solve problems identified during the investigation process.
Identify and manage the execution of continuous improvement projects.
Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint.Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components.
Ensure all quality issues are resolved to customer satisfaction, in a timely manner.
Resolve issues relating to product or production quality by interfacing with internal and external customers.
Management responsibilities include:
Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environment
Day-to-day operations of a group of employees;
May have limited budgetary responsibility and usually contributes to budgetary impact;
Interpret and execute policies for departments/projects and develops.
Recommend and implement new policies or modifications to existing policies.
Provide general guidelines and parameters for staff functioning.
Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.
MINIMUM JOB REQUIREMENTS
Education
Typically requires a Bachelor's degree in Engineering, Science, or Technical Field.
Work Experience
At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).
Knowledge / Skills / Abilitie
Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)
Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.
Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).
Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).
PREFERRED JOB REQUIREMENTS
Work Experience
At least 2 years of supervisory/managerial experience preferred.
Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries preferred.
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