Stryker · 7 hours ago
Director, Quality Assurance
Mahwah, NJ
Full-time
Onsite
Director/Executive
$187K/yr - $312K/yr
7+ years expStryker is a leading company in innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. The Director of Quality Assurance will lead the Quality Assurance team, focusing on delivering key quality and compliance results through subordinate leaders across multiple sites.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Responsible for delivering key Quality, compliance and business results through managing subordinate Site Quality Assurance leaders
Ensures alignment of Quality programs within the COE (centre of excellence) strategies for the site(s)
Ensures appropriate quality systems and organizational structures are in place to meet quality expectations and business needs
Provide SGS quality leadership with periodical quality performance assessment for each manufacturing site
Ensure that there is effective and timely communication of product quality issues to ensure the mitigation of risk
Ensure that the site’s conformance and commitment to quality meets or exceeds customer requirements and the relevant regulatory standards
Sponsors an environment of compliance within Stryker by working with business partners to define and maintain expected quality standards
Champions a positive employee environment by promoting open communication, engagement and development of team members. Promotes a culture of trust, flexibility, teamwork and inclusiveness
Ensures effective processes in selection of competent talent and supports the development of future potential experts and leaders. Ensures effective training and performance management processes are in place and executed
Ensures the site(s) maintain continued certification to all regulatory bodies. Sponsors and ensure engagement in all internal and external audit programs such as Corporate, notified body & FDA inspections
Foster collaboration, develop partnerships, and participate in multi-disciplinary Quality teams across the region and with all internal and external stakeholders to shares best practices with other regions/sites
Leverage shared services and drive common processes to improve quality and reduce cost
Ensure deployment and exchange of regional talent and leverage geographic synergies
Ensures effective management and control of product/process deviations and implementation of effective corrective and preventive action
Qualification
Required
Degree in Engineering Degree with Science discipline or equivalent
Minimum of 15 years' experience in a technical role, 7 years of which in a Quality Management position in the Medical, Pharmaceutical, Bio-Medical/Pharma or Automotive manufacturing environment
Minimum of 7 years' experience and a proven track record of successfully creating and managing a highly talented, engaged and performing team
Leadership ability to develop and implement organization and functional strategy
Initiates, sponsors and implements change and a demonstrated track record in QA Improvement
Ability to develop organizational relationship and build trust
Works with a sense of urgency and attention to detail at all times
Solves problems by gathering data and using logic to arrive at decisions or solutions that achieve the desired outcome
Excellent data handling capability and analytical skills required
Makes timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions
Works cooperatively with others to produce innovative solutions
Demonstrates Initiative
Mentoring, coaching and performance management
Experience of managing inspections/audits by the FDA and other regulatory bodies
Knowledge of 21 CFR Part 820 and ISO 13485
Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools
Uses interpersonal, relationship-based skills to convince and influence others
Resolves conflicts and disputes by addressing multiple viewpoints to develop a mutually satisfying outcome
Possesses the ability to influence, motivate, and enable others to contribute to the effectiveness of the organization
Demonstrates success working with others, learning from others, and building consensus to achieve established goals
Effectively interacts and communicates with diverse internal and external audience
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase