Quality Senior Supervisor

Job Description

The Senior Quality Supervisor is responsible for providing quality assurance knowledge and hands-on support for all aspects of production operations, quality control activities and transfer of new product launches and, ensuring that all site operations remain compliant with all FDA regulations, ISO standards, customer requirements, and internal policies and procedures.

This role will be the owner of quality planning, validations, FMEA and risk analysis, capability studies, developing, reviewing, and/or revising procedures; variance and complaint investigation and resolution; root cause analysis; corrective and preventative actions; and all other areas of quality control programs in a GMP and ISO 13485 environment.

The Senior Quality Supervisor will supervise the team of Quality and be responsible for ensuring quality support to the various production areas.

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com .

Responsibilities

The Senior Quality Supervisor will be responsible for providing Quality representation and support in the ongoing development, evaluation, and improvements of CooperSurgical quality programs and systems; quality assurance testing methodology; internal and external audits; vendor qualifications; training initiatives and programs; cross-functional process improvement activities; and any other business initiatives requiring Quality support.

Essential Functions & Accountabilities:

• Follow and ensure that all personnel comply with FDA regulations, ISO standards, customer requirements, and SOPs as defined by CooperSurgical policies and procedures.
• Represent Quality in signing on Change Orders.
• Manage all Quality responsibilities for assigned manufacturing changes and transfer of new product launches, including but no limited to developing and executing process validation protocols and publishing reports, and the development of processes and supplier quality plans.
• Monitor (by performing process capability and performance studies); recommend improvements (to processes, procedures and systems) to increase quality compliance and/or to meet or improve productivity and specification standards; present improvement plans and obtain management approval; and implement approved improvements; provide any related reports and documentation required for implementation.
• Participate in installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ). Draft and/or review protocols and reports, quality/validate production processes.
• Ensure that all documentation is completed in a timely manner and follows established policies, practices, and procedures
• Responsible for quality personnel development, including coaching, training and performance appraisal. Assists with hiring and onboarding process.
• Manages all employee relations issues with Human Resources and Management to ensure company policies are being followed.
• Guide quality personnel in all the assigned responsibilities.
• Promotes a positive work environment in alignment with CooperSurgical mission, vision and values. Applies disciplinary actions as needed.
• Investigate customer complaints including root-cause analysis; develop and implement corrective action plans.
• Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
• Effectively communicate and interact in a matrix environment.
• Act as lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• Lead or support by providing quality representation for internal and external audits.
• Train Quality and Manufacturing personnel on specifications, inspection and testing activities, new product audits, and environmental controls to ensure understanding and compliance, request training, training support, and/or re-trainings as needed.
• Provide quality support and representation for cross-functional initiatives and projects. Use lean manufacturing root cause analysis / problem solving methods to identify opportunities to increase safety and quality compliance and to reduce cost, lead time, inventory and defects.
• Perform/ complete PFMEA’s and generate internal control plans.
• Perform other duties as directed by management
  
  
  

Qualifications

QUALIFICATIONS

Knowledge, Skills and Abilities:

• Working knowledge of regulated environments (ISO 13485, 21 CFR 820, and/or other regulations).
• Root Cause Analysis (CAPA/NCR) experience.
• Project management.
• Experience in planning Process Validation, IQ/OQ/PQ/MSA (software qualification)
• Knowledge of Statistical Analysis of data and related tools.
• Advanced computer capabilities including Microsoft Office software.
• Strong interpersonal skills, team player.
• Well organized, able to manage different responsibilities at the same time while working in a fast-pace environment.
• Problem-solving and critical thinking skills.
• Able to read and interpret blueprints and familiar with geometric dimension & tolerance (GD&T) procedures and requirements.
• Fluent in Spanish. Ability to communicate in English, both orally and written.
  
  
  

Work Environment:

• Get into productions rooms.
  
  
  

Experience:

• At least 5 years of work experience in Quality Engineering role or equivalent.
• At least 5 years of supervisory or managerial experience.
• Experience in medical device manufacturing. Experience working in a regulated environment (ISO 13485, 21 CFR 820 or other).
  
  
  

Education:

• Engineering degree in mechanical, electrical, industrial or similar career.
• Professional Certification in a related Quality / Engineering Association.
• Black Belt certified is a plus.
  
  
  

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.