Job Information
Olympus Corporation of the Americas Principal Quality Engineer, Complaint Process Excellence in Center Valley, Pennsylvania
Working Location: PENNSYLVANIA, CENTER VALLEY
Workplace Flexibility: Field
For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus (https://www.olympusamerica.com/careers) .
Job Description
The Principal Quality Engineer, Complaint Process Excellence is an experienced professional with wide-ranging experience and expertise in CAPA and Global Complaint Process to ensure regulatory compliance and patient safety.
Job Duties
Establish and uphold a unified framework for process governance that ensures compliance, enhances transparency, and fosters collaboration across all regions.
Ensure that process changes are logical and align cohesively with the broader end-to-end process.
Lead continuous improvement efforts to optimize the complaint management process, ensuring effectiveness, efficiency, and regulatory compliance.
Design and implement best practices for complaint handling,
Develop, review, and maintain standard operating procedures (SOPs) for complaint handling processes.
Lead Complaints Global CAPAs, ensuring timely identification, investigation, and resolution of quality issues.
Follow global CAPA procedures and guidelines in alignment with regulatory requirements.
Provide training to staff on quality systems, and regulatory requirements.
Serve as a subject matter expert on quality engineering practices and compliance.
Collaborate with cross-functional teams to assess the impact of quality issues on product safety and effectiveness.
Prepare and present CAPA reports to management and regulatory bodies as needed.
Work closely with other departments, such as R&D, Manufacturing, and Regulatory Affairs, to ensure alignment on quality objectives.
Job Qualifications
Required:
Bachelor’s degree in Engineering, Life Sciences, or a related field; Master’s degree preferred.
A minimum of 10 years of experience in quality engineering, quality assurance, or regulatory compliance within a relevant industry (e.g., medical devices, pharmaceuticals).
A minimum of 5 years of experience in CAPA.
Strong knowledge of quality management systems (QMS) and regulatory standards (e.g., ISO 13485, FDA regulations).
Analytical Skills: Strong ability to analyze data, identify trends, and perform root cause analysis using various methodologies.
Problem-Solving: Proficient in developing and implementing corrective and preventive actions to address quality issues.
Regulatory Knowledge: Familiarity with industry regulations and standards (e.g., FDA, ISO, GMP) to ensure compliance in all Process and CAPA activities.
Communication: Excellent verbal and written communication skills for effectively conveying information to cross-functional teams and documenting findings.
Collaboration: Ability to work effectively with diverse teams, fostering collaboration among engineering, production, quality assurance, and regulatory affairs.
Attention to Detail: A keen eye for detail to ensure thorough investigations and accurate documentation.
Technical Knowledge: Understanding of the product lifecycle and engineering principles relevant to the industry.
Continuous Improvement Mindset: Commitment to identifying opportunities for process enhancements and promoting a proactive approach to quality management.
Travel up to 20% of the time domestically or internationally, availability to take evening and early morning teleconferences.
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance*
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:
Work-life integrated culture that supports an employee centric mindset
Offers onsite, hybrid and field work environments
Paid volunteering and charitable donation/match programs
Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .
You Belong at Olympus
We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)