Quality Management Compliance Specialist (PENA)
The QMS Compliance Officer is responsible for ensuring the Quality Management Organization operates within the requirements of ISO 9001:2015 and IATF ISO 16949, using approved quality management systems including environmental monitoring, consumable provision (traceability) training, resource monitoring and the associated documentation.
They will assist and guide second line management, making best use of engineering, administrative and organizational skills to improve compliance, maximize productivity and efficiency.
To ensure ISO Compliance Management for all production and support groups. To include review of evidence of compliance including compliance matrices for all required personnel, training and all QMS required documentation, record management for compliance training.
To be accountable for system administration activities to document and record control groups, technical writing team, continual improvement unit and quality areas, as required on a regular basis.
- Assist in developing processes and documentation for compliance purposes for ISO and IATF documents.
- Co-managing corrective actions, training, SOPs, calibrations, internal and external audits, risk management, supplier management related to compliance.
- Assist in Managing corrective action effectiveness evaluation.
- Track and coordinate CAPA (to ensure effectiveness in root cause remediation.)
- Composing and reviewing technical documentations such as technical reports, development reports, risk assessments, process validation protocol/reports.
- Maintain records of software version validations as needed.
- Subject matter expert for all activities related to document control.
- Controlled document preparation, routing, supporting document creation/change system.
- Providing status reports on all work in process.
- Publishing controlled copies of approved documents (SOPs, forms, procedures, specifications, production batch records, training material, training quiz, etc.)
- Other manufacturing document control related tasks as applicable.
- Collaborate and guide multiple departments in the drafting and publishing of documentation and revise as necessary.
- Conducting internal audits to ensure that traceability is maintained throughout production.
- Lead front room/backroom activities as directed by management during regulatory agency registrar, ISO, UL, internal and customer audits.
- Assist in regulatory audits and conduct regular internal audits to identify potential weaknesses and areas of noncompliance.
- Assist in supplier qualifications both outgoing and incoming to maintain compliance to FMEA and DSS.
- Develop internal company compliance policies and enforce compliance to them.
- Make sure the organization has a clearly defined program for complying with the ISO 9001 and ISO 16949 IATF standards.
- Collaborate with other Panasonic manufacturing location colleagues to synergize systems, processes, documentation, policies and compliance programs.
- Create awareness throughout the organization regarding the requirements of the standards and the purpose for the Quality Management System
- Communicate with employees and second level management.
- Lead compliance training modules in the weekly New Hire Orientation
- Report to management concerning the organization’s compliance.
- Act in dealing with noncompliance situations, work with stakeholders to create realistic plans and follow through to effectiveness.
- Other duties as assigned.
Personal Protective Equipment (PPE) Requirements:
- To ensure the health and safety in the workplace and for the protection of our employees, wearing PPE is a requirement for some roles at PENA and may include equipment such as a full Tyvek suit, safety shoes, gloves, safety glasses, face mask, bump cap, and a full hazmat suit that includes a respirator.
The foregoing description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills and efforts or work conditions associated with the job. It is intended to be an accurate reflection of the general nature and level of the job.
Qualifications: Requirements - Required and/or Preferred
- Basic/Required: Bachelor’s degree in Business Management, Change Management, Quality Management, or a related field from a four-year College or University
- 5 years combined experience quality compliance management
- Strong project leader with excellent organizational and verbal skills
- Knowledge of and comfort with Microsoft Office Suite software including Access, Excel, Word, PowerPoint
- Strong ability and proficiency in collecting, analyzing, and presenting data
- Solid computer skills and demonstrated general working knowledge of Microsoft Project or equivalent project management software tools
- Effective planning, organization, time management, and problem-solving skills with a strong attention to detail
- Able to manage multiple concurrent tasks in a fast-paced environment, effectively prioritize work, and deliver quality results
- Self-starter who works well independently and an outstanding ability to follow up with minimal direction by seeking answers and a focus on team success
- Able to make appropriate decisions when confronted with obstacles, think about them before acting, and consistently resolve issues in creative and effective ways
- A strong work ethic with a “get the job done” approach and consistently delivers excellent customer service, both internally and externally
- Intuitive, adaptable, creative, and collaborative with excellent communication and interpersonal skills
- Collaborative nature with strong team building skills and willing to learn from and accept guidance from others
- Must have strong working-level knowledge of the English language, including reading, writing, and speaking English
- BA/BS Degree or equivalent experience
- Minimum 5 years combined experience in quality/QMS compliance, managing document control and/or document QC teams, performing regulatory QC submissions, configuring, administering, and user acceptance testing of Statistical analysis
- ISO documentation experience preferred.
- Experience in technical writing preferred, but not required.
- Multi-cultural work experience, Japanese organizational understanding a plus.
- Alignment to Panasonic’s seven (7) core principles (contribution to society, fairness and honesty, cooperation and team spirit, untiring effort for improvement, courtesy and humility, adaptability, gratitude)
Panasonic Energy of North America (PENA) is collaborating with Tesla at a massive battery factory near Reno, Nevada which is known for its quality of life and expansive outdoor adventures. Panasonic's role at the Gigafactory is to manufacture and supply cylindrical lithium-ion cells to Tesla for their electric vehicles and energy storage systems.
Over the past few years, the Gigafactory has grown to the largest lithium-ion battery factory in the world. Together with our partner Tesla, we continue to revolutionize the lithium-ion battery space and accelerate the world’s transition to sustainable energy and transportation.
Our mission at PENA is to make the vision of affordable Electric Vehicles a reality by producing the world’s safest, high quality, and lowest cost batteries. Through this effort we will create a clean energy society and our products will change society’s use of and perceptions of electric power.
In addition to an environment that is as innovative as our products, we offer competitive salaries and benefits.
Pre-employment drug testing is required. Due to the high volume of responses, we will only be able to respond to candidates of interest. All candidates must have valid authorization to work in the U.S. without restriction.
Panasonic is an Equal Opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, disability status, protected veteran status, and any other characteristic protected by law. All qualified individuals are required to perform the essential functions of the job with or without reasonable accommodation.
Thank you for your interest in Panasonic Energy of North America.