Overview
Sr. Associate II, Quality Control (External Testing Management) Jobs in Research Triangle Park, NC at Biogen
Workplace Flexibility: Onsite
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.
Job Description
This role is responsible to ensure compliance to the Quality Management System and all applicable regulatory requirements along with the business strategy of the company for the Site and serves as the Deputy Management Representative. This role, is responsible for monitoring, management and success for Site Key Process Indicators (KPI), to guide and lead CAPA coordinators, and to ensure CAPA activities are appropriately and consistently executed in compliance with global requirements.
Job Duties
Serves as the Deputy Management Representative for the Site.
Manages local QMS team in accordance with organization policies and objectives. Provides guidance to staff regarding work priorities and projects.
Leads Audit Readiness, participates in Quality System Audits by 3rd Parties, and internal Olympus compliance groups to demonstrate compliance to regulatory requirements and the Quality System.
Ensures audits conducted which result in deficiencies are corrected per policy.
Leads and guides CAPA coordinators in the Americas. Hosts Regional CAPA progress meetings
CAPA process expert, may attend Global CAPA Board, CAPA communities of practice.
Leads the local CAPA Review Board meeting and supports CAPA owners to close them in timely manner.
Monitors key performance indicators and leads the monthly KPI meetings.
Supports the management representative in preparation for Quarterly Management Review meetings.
Coordinates with other Sites and functions to ensure accurate complete and efficient change processing.
All Other Essential Duties as directed.
Job Qualifications
Required:
Bachelor’s degree in engineering, technical discipline, or equivalent
Minimum of 10 years of experience supporting, or working within, a medical device, or similar regulatory controlled industry.
Self-Starter with strong leadership, organizational, proven problem-solving and decision-making capabilities
Provides constructive feedback, coaching and mentoring
Excellent interpersonal skills and experience working with different cultures and levels of management
Ability to persuade people with wider perspectives to accomplish objectives
Excellent verbal, written and presentation skills
Strong analytical, time management, and organizational skills with focused attention on detail
Ability to work well under pressure in a fast-paced environment and meet deadlines with a high degree of accuracy
Ability to understand business needs/requirements and system capabilities to develop efficient and effective solutions
Proficient with DMAIC / Six Sigma type tools to analyze, drive root cause, and solve problems
Highly proficient in Microsoft Word, PowerPoint, Excel, Visio, Project
Ability to travel up to 5-10% of time domestically and internationally. Potential for work outside of normal business hours to support global projects and initiatives.
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.
The anticipated base pay range for this full-time position working at this location is $128,775.00 – $180,285.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
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 [email protected]. 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) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA)
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Title: Sr. Associate II, Quality Control (External Testing Management)
Company: Biogen
Location: Research Triangle Park, NC
