Quality auditor Jobs in Athens, GA

Process Quality Leader

We are searching for the best talent for the Process Quality Leader located in Cornelia and Athens, Georgia.

Purpose: The Process Quality Leader will supervise individual contributors and/or supervisors, and is accountable for conducting effective performance management. Evaluates existing processes, analyzes implemented changes, and recommends adjustments to workflows, schedules, or other processes. Executes and coordinates studies aimed at improving product quality, efficiency, and reliability. Certifies internal quality audits and provides reports on quality metrics to the other members of the Quality and management teams. Oversees a team of Business Process Quality associates and trains them on the latest product standards and processes. Responsible for managing operational aspects of their team (e.g., workflow, performance, and compliance), as well as ensuring achievement of team goals within expected standards. Understands and applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with team.

You will be responsible for:

• Supervising individual contributors and/or Supervisors, and is accountable for conducting effective performance management.
• Coordinating processes and assignments for supervisors and individual contributors to achieve Manufacturing Process Improvement goals.
• Coaching less experienced staff on how to align metrics and operational areas of focus to drive profitability and best-in-class service delivery.
• Advising on identifying and implementing cost saving measures to drive profit optimization and operational efficiencies.
• Guiding team on policies and procedures to ensure compliance and achievement of the organization's objectives for the Manufacturing Process Improvement area.
• Under the direction of the Business Unit Manager, the PQL provides technical leadership towards the Identification of the causes for non-conformances and process' failures, and for the implementation of the remedial, corrective and preventative actions thus assuring process performance and compliance against Ethicon's QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process.
• Reviewing and analyzing quality trends with the manufacturing team. Considering the quality trends provides direction in terms of setting work priorities for process enhancement.
• Providing guidance to manufacturing supervisors to ensure the effective in-depth investigations are performed.
• Providing leadership and guidance to cross functional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented. Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.
• Leading investigations of the negative trends and in alignment with the Process Engineer and the Manufacturing Manager, facilitates the implementation process.
• Analysis of data and based on the trends recommends actions for process, equipment and system improvement.
• Writing procedures, protocols and any other Documentation needed for the enhancement of processes and systems.
• Providing training and education to the manufacturing team on tools for process evaluation and enhancement. (Analytical trouble shooting, FMEA, statistical concept application and QSR/ISO requirements.
• May lead a number of CAPA and should recommend CAPA's based on negative trends.
• Handling, preparing data and present product escalation investigations (PRE's), near misses and QRB.
• Leading in-process investigations with multifunction team to determine root causes and provides recommendations for corrections on preventive actions.
• Handling preliminary investigations of product complaints, analysis, trends and recommendations or leads corrective/preventative actions.
• Providing technical supervision to multilevel, cross functional teams. Provides supervision to technical professionals such as College Recruits, Coops or Supervisors that are assigned to work on projects related to process enhancement initiatives.
• Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed.

Qualifications / Requirements:

• Bachelor Degree in Engineering or Science is required. Master's Degree preferred.
• A minimum of five (5) years of experience in the QSR/ISO required-regulated medical device operation preferred.
• Experience in a quality role within the manufacturing industry preferred.
• Advanced computer skills (Microsoft Office) and use of software application (s) are required.
• Must have thorough knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniques.
• Proficient in the preparation of technical reports and presentations.
• Strong communication and interpersonal skills.
• Requires good negotiation skills. Entails heavy interaction with technical peers and manufacturing associates, in operations in the mainland.
• Position requires leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills.
• May requires working/visiting all three shifts of the operation and working irregular hours.
• Will require sitting for extended periods of time, writing reports on the computer.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Required Skills: Business Process Management (BPM), Business Requirements Analysis, Business Savvy, Compliance Management, Developing Others, Fact-Based Decision Making, Inclusive Leadership, ISO 9001, Leadership, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Standard Operating Procedure (SOP), Strategic Thinking, Tactical Thinking, Team Management

Preferred Skills: Business Process Management (BPM), Business Requirements Analysis, Business Savvy, Compliance Management, Developing Others, Fact-Based Decision Making, Inclusive Leadership, ISO 9001, Leadership, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Standard Operating Procedure (SOP), Strategic Thinking, Tactical Thinking, Team Management

The anticipated base pay range for this position is: $94,000.00 - $151,800.00

Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay, including Floating Holidays 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave 80 hours in a 52-week rolling period 10 days Volunteer Leave 32 hours per calendar year Military Spouse Time-Off 80 hours per calendar year For additional general information on Company benefits, please go to: -