Quality Engineer II

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Key Responsibilities:

• Champions compliance with applicable Global Regulations and standards (e.g. QSRs ISO EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.

• Conducts investigation bounding records documentation review and approval of non-conformances CAPAs and customer complaints. Raises quality issues as appropriate.

• Accountability for material identification material segregation classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.

• Analyzes/reviews effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.

• Represents as a Subject Matter Expert (SME).

• Supports or leads in developing validation strategies.

• Partners with J&J Global Supply Chain Finished Goods and material suppliers to ensure appropriate application of process validation process control and risk management and the investigation/correction of process failures when needed.

• Collects data and executes/conducts various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.

• Documents justifies reviews or analyzes whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs.

Qualifications

Education:

• A Bachelors or equivalent university degree in Engineering or related scientific field is required.

Experience and Skills:

Required:

• A minimum of 0-2 years of relevant professional work experience in the Medical Devices industry.

• Strong knowledge of quality management systems and regulatory requirements (e.g. ISO 13485 FDA QSR).

• Exceptional problem-solving and analytical skills with the ability to identify root causes and implement effective solutions.

• Excellent communication and interpersonal skills with the ability to collaborate effectively with cross-functional teams.

• Experience with CAPAs non-conformances audits and process validation.

• Strong trending and data analysis skills.

• Proven competence to evaluate communicate and act upon significant risks demonstrating leadership of the high standards of quality and compliance.

• Act with speed flexibility and accountability to achieve goals. Understands how own work impacts the enterprise and use understanding to make effective decisions and take actions and lead priorities effectively to deliver expected results.

Preferred:

• Process Excellence / Six Sigma Certification or equivalent.

Other:

• This position may require up to 10% of domestic or international travel.

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The anticipated base pay range for this position is :

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