Senior Quality Systems Engineer - CAPA

BD; United States; Remote; USD 99,000 - 164,000; Full time

Job summary

Join BD as a Sr. Quality Systems Engineer, where you'll develop and manage quality systems ensuring compliance with industry regulations. You'll collaborate with cross-functional teams and conduct audits to improve processes. If you're passionate about quality assurance and want to make a difference in health technology, we encourage you to apply.

Qualifications

• Minimum 5 years of experience in quality assurance or a similar role.
• Experience managing CAPA processes and conducting audits.
• Familiarity with ISO standards and regulatory requirements (FDA, GMP, etc.) is a must.

Responsibilities

• Develop and manage quality systems for compliance with regulations.
• Conduct audits and inspections to identify improvement areas.
• Investigate customer complaints and recommend corrective actions.

Skills

Quality management principles

Communication skills

Attention to detail

Organizational skills

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

SAP QMS

TrackWise

Job description

Job Description Summary

Develop and sustain quality system CAPA and processes for the Design Center that comply with applicable regulations and standards, Corporate and Business Unit policies and procedures. Identify gaps in existing practices against the procedures and close those gaps.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Job Summary:
As a Sr. Quality Systems Engineer, you will be responsible for planning and implementing corrective actions (CAPA) to address quality issues including and developing and managing quality systems to ensure compliance with regulations and industry standards. Additionally, you will conduct regular audits and inspections to identify areas of improvement and provide recommendations for corrective action.

Responsibilities:

• Develop and manage quality systems to ensure compliance with regulations and industry standards.

• Collaborate with cross-functional teams to develop and implement quality control plans, procedures, and protocols.

• Conduct regular audits and inspections to identify areas of improvement and provide recommendations for corrective action.

• Monitor product performance and trends to identify potential issues or opportunities for improvement.

• Investigate customer complaints and provide detailed reports on findings and recommendations.

• Provide training and support to employees on quality processes and procedures.

• Stay up-to-date on emerging trends and technologies in quality management and regulatory requirements.

• Collaborate with external partners such as suppliers, vendors, and regulatory agencies to maintain relationships and communicate quality expectations.

• Maintain records of all quality activities including documentation, testing results, and nonconformity reports.

• Investigating and analyzing: Identifying and investigating product and quality issues, and determining root causes

• Implementing corrective actions: Planning and implementing corrective and preventive actions (CAPA) to address quality issues

• Documenting and reporting: Maintaining records of investigations, findings, and corrective actions, and preparing reports for management review

• Collaborating: Working with cross-functional teams to resolve issues and develop CAPAs

• Communicating: Communicating with stakeholders at all levels, including management, peers, and key stakeholders

• Supporting training: Supporting the delivery and oversight of CAPA training programs

• Supporting audits: Providing subject matter expertise during audits and inspections

• Supporting process improvement: Leading and contributing to continuous improvement initiatives and projects

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field.

• Minimum 5 years of experience in quality assurance or similar role within a regulated industry (e.g., medical device, pharmaceutical).

• Previous experience managing CAPA processes and auditing

• Strong understanding of quality management principles, ISO standards, and regulatory requirements (FDA, GMP, etc.) and MDSAP program

• Proficiency in quality system software such as SAP QMS, TrackWise, etc.

• Excellent communication skills both written and verbal.

• Ability to collaborate effectively across functional teams.

• Attention to detail and strong organizational skills.

• Self-motivated and proactive in identifying and resolving problems.

• Familiarity with statistical analysis techniques and tools.

• Familiarity with root cause analysis techniques and tools.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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Required Skills

Optional Skills

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Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

USA CA – Brea

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$99,000.00 - $163,300.00 USD Annual

About the company

210136 Becton, Dickinson and Company, commonly known as BD, is an American multinational medical technology company that manufactures and sells medical devices, instrument systems, and reagents.

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