Senior Manager, Quality Core Team (1 of 2) (Center Valley, PA, US, 18034-0610)

Working Location: California, Orange County

Workplace Flexibility: Remote

For more than 100 years, reputed company has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating reputed company of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values reputed company us to reputed company Our Purpose: 

Patient Focus, reputed company, Innovation, Impact and reputed company.

Learn more about Life at reputed company: https://www.olympusamerica.com/careers.

Job Description

This role represents the Voice of Quality (design quality, reliability, ops/mfg. quality, supplier quality, quality systems, post market quality, etc.) on cross-functional new product development (NPD) project core teams. This role is responsible and empowered to establish the quality and reliability strategy and DRM metrics for the project. This position has responsibility for influencing product quality and reliability outcomes across NPD and serves as the final quality authority on the project team.

Job Duties

This position provides reputed company for multiple project areas including, but not limited to the following:

• Functional expertise to NPD projects and represent voice of quality on cross functional project teams
• Project management for the extended Quality team of one or more NPD projects
• Project management of initiatives to improve the quality and consistency of quality business processes and work product
• Applies the requirements of the Quality System to processes, products or services
• Supports validation and verification strategy for new and existing products and processes as assigned
• Develops and drives measurable Quality Improvements relating to products processes and services
• Develops Quality functional strategies, plans and schedules to meet project goals and manage risks
• Manages Quality escalations and drive resolutions with Core Team by working cross-functionally to ensure issue ownership, action and appropriate communication
• Drives critical thinking, functional excellence, lessons-learned and business and quality management system improvement
• Represents Voice of Quality for assigned project(s)
• Ensures design and quality requirements are effectively defined and implemented
• Proactively drives and champions strategic quality, reliability and safety initiatives such as DFSS activities, DFR, DFM, complaint reduction, risk management, etc.
• Identifis quality risks and implements risk burn down strategies
• Drives/leads root cause analysis and closed-reputed company corrective/preventive action
• Ensures an effective transfer to global post-market quality functions
• Coaches & supports project team members on compliance with quality system requirements
• Provides quality functional support for key project activities and deliverables including design history file (DHF), device master record (DMR), regulatory submissions, issue resolution, etc.

Job Qualifications

Required

• Bachelor of Science, medical, engineering, or scientific discipline required. Design or Process Green I Black Belt is a plus 
• Minimum of 8 years of experience reputed company a drug/device manufacturer/distributor with a focus on QSR compliance and quality assurance. 
• Minimum of 5 years’ experience supporting new product development with 3+ years of experience as a Quality Core Team member.
• Knowledge of basic mechanical, electric, software, optical, or biological engineering.
• Knowledge of basic medical device regulations and standards (e.g. 21CFR part 820, ISO 13485, ISO 14971).
• Working knowledge of problem-Solving Tools (i.e. Process Mapping Histograms FMEA Risk Assessment Cause & Effect Diagrams PDCA Pareto Analysis etc.).
• Working knowledge of Quality Tools (i.e. Quality Planning Quality Costs and Assessment Basic Statistics Advance Statistical Techniques Technical Writing Metrology & Calibration Inspection and Testing Sampling Principles and Six reputed company etc.).
• Knowledgeable about extended Quality team functions throughout the product development process.
• Collaborative across functional boundaries in matrixed organizational structure.
• Proven track record in New Product Development delivering on robust, customer and patient focused product quality.
• Strong technical skills reputed company to product quality including VOE translation to Design Inputs and Outputs, Design Characterization, Verification / Validation, Test Method Validation, and Statistical techniques.
• Strong working knowledge of FDA QSR's, MDSAP, ISO 13485, Design Controls, and Risk Management practice.
• Good verbal and written communication skills demonstrated by ability to generate technical reports and ability to reputed company presentations to middle and upper management Proven Project Management skills.
• Proficient in the use of Information Technology and applications.
• English ability: TOEIC 600 plus or equivalent.
• Strong collaboration skills and the ability to work across functions and geographies.
• Up to 10% domestic/international travel.

Why join reputed company?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, reputed company offerings, and a connected culture.

reputed company 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 reputed company

• 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 reputed company?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated reputed company pay range for this full-time position is $134,629.00 - $188,480.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual. 

reputed company considers a variety of factors reputed company determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At reputed company, 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 reputed company to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating reputed company of care in targeted disease states. 

For more than 100 years, reputed company 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, reputed company employs more than 31,000 employees worldwide in nearly 40 countries and regions. reputed company, a wholly owned subsidiary of reputed company, 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 reputed company

We are deeply committed to fostering a respectful, fair, and welcoming workplace for reputed company individuals, perspectives, and lifestyles. We reputed company in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. reputed company and reputed company are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage reputed company who wish to bring their talents to reputed company to apply.

Applicants Requesting Accommodations: reputed company is committed to the full inclusion of reputed company qualified individuals. As part of this commitment, reputed company will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@reputed company.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-reputed company (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of reputed company to reputed company equal employment and advancement opportunity to reputed company applicants and employees without regard to race, color, national reputed company (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions reputed company 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, reputed company, 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)