Job description
POSITION SUMMARY
The Quality Control Manager is responsible for the design, implementation and maintenance of Quality Assurance protocols and methods for processing materials into finished or partially finished products. The Quality Control Manager is responsible for planning, implementing, and managing processes in compliance with applicable safety, quality, and regulatory requirements for ProMed product distribution. The Quality Control Manager ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.
ESSENTIAL DUTIES & RESPONSIBILITIES
Position duties and responsibilities include, but are not limited to the following:
Serves as site Management Representative - host audits, identify appropriate quality data, provide independent review of quality system performance at all levels and reporting any issues;- Facilitates third-party audits and inspections; coordinates responses to the audits/inspections and ensures that findings are addressed appropriately;
- Ensures that the Quality Management System and the processes needed to ensure product quality are implemented, understood, and maintained; ensure that issues requiring improvement are identified and fed to CAPA appropriately;
- Communicates directly with designee(s) at ProMed’s manufacturing sites regarding changes made to the quality system affecting regulatory submissions; communicates within the supply chain for matters relating to the quality system;
- Regularly monitors performance of the Quality Management System and communicates deficiencies to responsible personnel;
- Maintains knowledge of federal, state, and local regulatory requirements applicable to work performed ProMed’s manufacturing facilities;
- Refines and implements regulatory practices as needed to meet regulatory compliance;
- Serves as process owner for Management Review;
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth;
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements;
- Meets expectations of regular, reliable attendance;
- Other Duties As Needed: Any other duties and tasks as deemed necessary and appropriate.
QUALIFICATION, EDUCATION & EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
- Bachelor's degree Engineering or Life Science or experience of such kind and amount as to provide a comparable background;
- Minimum five (5) years’ experience in quality systems experience; management experience required;
- Knowledge of quality tools and principles;
- Knowledge of medical device regulation (21 CFR 820), QMS Standard ISO 13485, risk management (ISO 14971) and U.S. Food & Drug Administration (FDA);
- Proficiency in statistical, quality and continuous improvement methods and tools;
- Knowledge of Coordinate Measuring Machine (CMM) dimensional measuring equipment, pin gages, and calipers, as well as other equipment as required;
- Knowledge of Statistical Process Control (SPC), Minitab, SQC pack, design of Methodology and blueprint reading;
- Must have Intermediate knowledge of Microsoft Office products to include, Word, Excel, PowerPoint, Outlook, and Project;
- Commitment to continuous improvement company-wide;
- Excellent communication and interpersonal skills both written and verbal; professional, courteous and friendly personality; clearly conveys ideas and information and receives information effectively;
- Excellent organizational, problem-solving and time-sensitive skills;
- Ability to create positive working relationships with a diverse group of people including gender, ethnicity, age, and cultural and skill level differences;
- Ability to work independently with minimal supervision;
- Ability to establish priorities and meet deadlines.
Preferred:
- Professional certification (i.e. ASQ, Six Sigma, etc.) preferred.
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