DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
The Quality Systems Manager will oversee and manage the execution of Quality Systems (QS) at the site level, including Change Control, Records Management, Nonconformances (NC), Corrective and Preventive Action (CAPA), Customer Complaints, Quality Progress Review (QPR), Quality System Management Review (QSMR), Field Action Investigations and other assigned QS activities to ensure systems are effective and in compliance.
MAIN DUTIES & RESPONSIBILITIES:
• Responsible for the consistent and correct execution of QS global procedures within the site to ensure the quality and compliance of processes and records for Change Control, Records Management, CAPA, NC, Customer Complaints Investigations, QPR and QSMR and Filed Action Investigations.
• Develops competency of resources within the site that execute CAPA, NC, Customer Complaints, QPR and QSMR, by providing training and guidance on the execution and documentation of these processes.
• In partnership with the site Quality leaders, oversees the timely and compliant execution of site NCs, CAPAs, Customer Complaints, QPR and QSMR, by championing collaboration across functions and sites and developing action plans, as required, in order to improve or sustain associated metrics at target levels.
• Leads a governance process to ensure flawless execution of site QPRs and QSMRs according to global procedure requirements.
• Oversees the timely site collection, escalation and reporting of all Quality System metrics to management.
• In partnership with the site Quality leaders, oversees the Product Escalation process for non-conformances, complaints or other issues potentially impacting product in the field. Reviews related investigations and corrective action plans to avoid reoccurrence of the nonconformity. Ensures timely closure of escalations.
• Identifies needs to meet and improve system performance of NC, CAPA, Customer Complaints, QPR and QSMR at the site level, and escalates to appropriate representative and management in a timely manner.
• Collaborates with The Regional Quality System Leader in the deployment of QS initiatives impacting the site that promote the continuous improvement of the QS and ensure continuity of the application of globally shared processes and systems at site level.
• Supports compliance activities by participating in audit readiness; assisting in Internal and External audits; serving as Subject Matter Expert for Change Control, Records Management, NC, CAPA, Customer Complaints, QPR and QSMR during audits; managing the investigation, response, and remediation of site-specific QS audit observations.
• Oversees the execution of Document Control across the site. Partners with Global QS in the implementation of system improvements and training deployment, as required.
• Other Quality Systems related tasks, responsibilities, and projects as assigned.
Scope of operation encompasses multiple direct reports within the site, including:
• Document Control analysts
• CAPA and Complaint Coordinators
KEY COMPETENCIES REQUIRED
• Universal Leadership Competencies: (Connect) Cultivate external relationships and partnerships, Forge internal collaboration across all levels of the enterprise, (Shape) Challenge the status-quo; lead and adapt to change, take and manage risks, (Lead) take ownership for talent acquisition, performance and development of self and others, Engage in transparent and constructive conversations
• Differentiating Competencies: (Connect) Be insight-driven to uncover unmet needs, (Shape) Translate insights into viable products and solutions that create value, (Deliver) Empower people to act with speed, agility and accountability
• Specific Technical Skills Required: Project Management; Technical Writing; Quality System Integration, Quality Auditing, and Risk Management knowledge. Ability to apply principles of logical or scientific thinking, root cause and statistical analysis. Presentation Skills. Working experience of applicable software (Microsoft Word, Excel, Power Point, Microsoft Project)
• At a minimum, BS degree in Engineering / Scientific or associated relevant technical / Quality discipline is required; Engineering degree preferred
• Five (5) years related experience in Medical Device or Pharmaceutical, or Aerospace environment, or equivalent combination of education and experience is required
• Solid knowledge of ISO and QSR regulations required; experience with front and back room leadership in third party inspections required.
• Experience with root cause investigation and change management is required.
• Experience with training or coaching others is required.
• Direct supervision experience is required.
• Strong communication, influencing and leadership skills: ability to communicate at all levels of the organization, and to interact with and influence cross-functional and cross-business teams to drive results is required.
• Strong business acumen, interpersonal skills relating to teams with diverse cultures and business practices is required.
• Strong verbal and written communications skills for multi-level stakeholders.
• Strategic and tactical execution abilities, including strong organization skills is required.
• The ability to take initiative regarding innovative approaches to problem solving in a fast-paced, changing business environment is required.
• A Certification in process excellence preferred.
• This position will be based in Elmira, NY and requires up to 10% travel