Job Summary
Senior Director, Quality TECA will be accountable for the development, execution, and delivery of quality strategies for DS TECA lifecycle management (LCM) and new product introduction (NPI) engineering activities.
- Acts as the Quality Management Representative for Synthes West Chester, PA sites: Headquarters, Technology Center, and Wilson Drive Development Center.
Duties & Responsibilities
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Will be a member of DS TECA Platform Operating Committee and will provide the quality strategic vision for the organization.
- Will provide guidance and coaching to all levels within the Quality organization and Quality leadership for the business.
- Will partner with R&D, Supply Chain, Regulatory & Marketing to assure all LCM/NPI engineering and quality deliverables are met within quality, cost, and schedule targets.
- Will partner with R&D, Supply Chain, Regulatory & Marketing to assure there is appropriate execution of risk management, design controls and process validation for new and existing products.
- Will manage overall quality budget, ensuring effective allocation of resources and investments to achieve quality objectives.
- Will be accountable for quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed.
- Will be responsible for the Synthes Quality Management Review.
- Will support Quality related activities for product issue escalation, investigations (PIE/PIA) and QRB.
- Will partner with Supplier Quality and Manufacturing, to ensure Quality strategy is aligned with J&J Med Tech Quality strategies.
- Will host FDA/TUV/BSI and other Health Authority audits.
- Responsible for communicating business related issues or opportunities to next management level.
- 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.
Experience & Education
- A minimum of a bachelors degree in a technical field is required.
- A minimum of 12 years quality assurance management experience in medical devices is required.
- Strong knowledge of design control requirements is required.
- Direct experience leading Notified Body/FDA audits is required. Strong knowledge of FDA and EU regulatory compliance for Medical Devices is required.
- Previous experience managing multiple projects is a required.
- Experience of developing concise and audience-focused communications, both written and for presentations is required.
Required Knowledge, Skills, Abilities, Certifications/Licenses & Affiliations
- Strong problem solver with a proven ability to identify multiple possible solutions when faced with quality issues/opportunities.
- Ability to effectively present complex information in a clear and concise manner is required.
- Strong relationship builder who can earn the trust of internal and external stakeholders such that quality is positioned to contribute in a strategic, proactive way.
- Ability to effectively negotiate and influence upper management, other departments and regulatory agencies is required.
- Highly motivated individual with excellent interpersonal communication skills, and strong facilitation and executive coaching skills.
- Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details is required.
- Experience of developing concise and audience-focused communications, both written and for presentations is required.
- Excellent communication and interpersonal skills are required.
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Additional information can be found through the link below.
Co-Ops and Intern Positions: Please use the following language:
Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan.
Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year.
Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension).
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
