The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting a Project Manager, Supplier Quality Compliance, to be located in Irwindale, CA ir Irvine, CA.
The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster, Mentor, SEDASYS® and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
This role is specific to Biosense Webster: Biosense Webster is the world leader in the $2.5 billion worldwide electrophysiology market and our company is in the enviable position of being one of the fastest growing businesses within Johnson & Johnson. We have achieved double digit growth consistently over the last decade and aren’t stopping as we look towards the future. Our product portfolio remains strong and further proves we are an innovative leader in cardiac electrophysiology. In order to continue this great growth trajectory, we need to bring on board top talent like you to help fuel our future! Our growth has also enabled a relentless focus on talent development by providing many new opportunities for our employees to expand their knowledge and grow their careers. Our commitment to developing our leaders is unwavering. Our investment in people, technology, and innovation make us one of the best places to work within one of the most admirable corporations in the world.
Principal Duties and Responsibilities
- Develop and execute organizational and operational policies for the franchise wide quality system supplier quality audit program.
- Manage external auditors/contract auditors.
- Make decisions regarding work processes or operational plans and schedules in order to achieve department objectives
- Assess proposed regulations and communicate new requirements to the organization
- Alert organization to existing and potential problems and risks.
- Provide compliance and quality consultation services.
- Collaborate with functional department to establish effective CAPAs.
- Conduct supplier audits and gap assessments in support of the supplier quality audit program and FDA readiness.
- Ensures audit reports are issued within the prescribed time frame.
- Monitor supplier quality audit program performance through the use of trending and metrics.
- Serve as a consultant, making recommendations and corrective actions, which are required regarding audit results, and compliance to written procedures or applicable government regulations.
- Maintain files containing audit reports, re‑audit reports, and audit responses, and pertinent corrective action follow-up for audits conducted in support of the supplier quality audit program.
- Review audit responses and assist with required training in response to audit findings and other GMP/ISO/JPAL related issues as needed.
- Provide advice and guidance to less seasoned quality system auditors.
- Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.
- Engages in constructive conflict.
Ensure effective supplier quality audit program. Ensure effective FDA Readiness program for key critical suppliers. Accountable for the absence of significant quality issues and regulatory compliance actions by government agencies. Accountable for the proactive identification and alerting of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business. Accountable for effective regulatory agency inspections.
Required and Preferred Qualifications
Education and/or Experience
- B.S. in scientific or technical field is required.
- Minimum of 5 years experience in quality compliance with recent experience in the medical device and diagnostics industry is required.
- Certified quality auditor and or lead auditor preferred.
Other Skills and Abilities
- Progressive quality systems experience, quality control, quality assurance experience, including hands on advanced quality systems compliance is required.
- Strong leadership ability, interpersonal, communication, and influencing skills are required.
- Demonstrated compliance experience in domestic and international medical device and combination product quality systems preferred.
- Ability to analyze, balance, and prioritize risk is required.
- Good written and oral English communication skills are required.
- Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents preferred.
- Significant understanding in FDA CFR Part 820, Part 11, and ISO 130485 regulations is required.
- Ability to select, manage and direct a team during an audit is required.
- Ability to respond to common inquiries, regulatory agencies, or members of the business community is required.
- Strong statistical skills and manufacturing process understanding are required.
- Ability to lead a team through a root cause analysis problem is required.
- Ability to effectively present information to top management, public groups, and/or boards of directors is required.
- A high tolerance for ambiguity in a complex environment is highly preferred.
- The ability to makes the complex clear and easily understood by others is highly preferred.
- This position can be located in either Irwindale or Irvine, CA.
- This role will require travel.
- This role will require the incumbent to travel between Irwindale and Irvine, CA multiple times per week.
United States-California-IrwindaleOther Locations
North America-United States-California-IrvineOrganization
Biosense Webster Inc. (6010)Job Function
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