Sr. Quality Manager
Job Description
As a Senior Quality Manager, you'll play a pivotal role in ensuring the highest standards of quality and compliance. You will lead a team of professionals, fostering a culture of excellence and driving continuous improvement. Your expertise will be instrumental in maintaining a robust Quality Management System (QMS) that meets regulatory requirements and exceeds customer expectations.
Job Responsibilities:
- Manage and lead a team of Quality Engineers and Associates, providing guidance and mentorship in quality and medical device best practices.
- Develop, maintain, and execute quality procedures to inspect and report quality issues, ensuring products meet specifications.
- Oversee the maintenance and effectiveness of the ISO quality system, driving continuous improvement and compliance.
- Lead internal and external audits, including CAPA, NCR, and customer complaints, ensuring thorough investigation, root cause analysis, and documentation.
- Ensure document control, revision control, and process validation activities comply with regulatory requirements.
- Collaborate with purchasing and co-manage the approved supplier list, evaluating suppliers for product compliance.
- Foster a "culture of quality" by providing resources, support, and recommendations for growth.
- Communicate effectively with management and stakeholders, upholding corporate values of safety, quality, ethics, and innovation.
- Bachelor's degree in quality, risk management, mechanical or industrial engineering, or equivalent experience.
- 8+ years of professional experience in quality management for medical device manufacturing, with progressive scope and responsibility.
- Proven leadership and team management skills, with experience leading a diverse QA and QC team.
- Certifications such as CQA, CQE, Lead Auditor, or Internal Auditor preferred.
- Extensive knowledge of ISO 13485, 21 CFR 820, MDSAP, PPAP, Control Plans, PFMEA, GRR, and MSA.
- Strong customer management, conflict resolution, project management, and decision-making abilities.
- Excellent communication skills, both written and verbal, with a talent for presentations.
- Experience in disposable products/cleanroom manufacturing is preferable.
- Familiarity with REACH, RoHS, and Conflict Material Surveys is required.
Meet Your Recruiter
Alejandra (Aly) Mora
Aly Mora is a devoted Technical Recruiter specializing in the dynamic Automation Division. With a rewarding 2-year tenure at Sterling, Aly’s passion for shaping people's careers and adeptness at navigating the competitive recruitment landscape make her a standout professional.
As a Technical Recruiter within the Automation Division, Aly brings a deep understanding of the industry's particulars, enabling her to expertly match skilled professionals with positions that align with their talents and aspirations. Her commitment to finding the perfect fit drives her to facilitate transformative career moves.
What Aly enjoys most about recruiting is the opportunity to shape people's careers positively. She takes pride in matching candidates' skills with the right job - witnessing their growth and success as they navigate their professional journeys. Aly is fueled by knowing she plays a pivotal role in her candidates' achievements.
In addition to her dedication to candidates, Aly extends her expertise to advising job seekers. Her advice is rooted in thorough research, urging candidates to invest time in understanding the company they're applying to, its values, culture, and industry presence. She believes informed candidates can ask insightful questions during interviews, showcasing their genuine interest and proactive attitude.