Secant Group · 1 day ago
Quality Engineering Manager
Quakertown, PA
Full-time
Onsite
Senior Level
5+ years expSecant Group is an advanced technology biomaterials company headquartered in Telford, Pennsylvania, providing innovative solutions for the medical device, pharmaceutical, aerospace, and energy markets. The Quality Engineering Manager is responsible for the development and maintenance of manufacturing and quality management systems, ensuring compliance with regulatory standards and customer requirements.
Enterprise SoftwareInformation TechnologyMobile AppsSoftware
Hiring Manager
Denise Zavalis
Responsibilities
Performs and documents timely Corrective and Preventive Actions (CAPA) investigations
Performs and documents customer complaint investigations, performs root cause analysis and develops corrective and preventive actions. Works with customers to provide required technical support and information regarding the investigation
Acts as lead on assigned CAPAs to drive corrective actions and closure of CAPA within prescribed timelines
Completes Supplier Corrective Action Requests (SCARs) and communicates with suppliers in regard to non-conformances, supplier changes, etc
Performs product support for product development and commercial products (reviews/approves product specifications, customer drawings, product validations protocols)
Performs statistical data analysis utilizing statistical software (Minitab and Excel)
Develops and implements statistical methods and designs experiments to support process control and process/product improvement
Performs physical and visual Test Method Validation/Gage R & R activities by developing and executing protocols for new or existing processes
Performs Risk Management activities utilizing risk management tools (pFMEAs (Process Failure Mode and Effect Analysis), etc.)
Supports development and implementation of methods for sampling, inspection, testing and evaluation of products
Interfaces with customers to provide technical support for our products/complaints/change control
Reviews/approves applicable validation and qualification documents for compliance with internal procedures (Installation Qualification (IQ), Operational Qualification (OQ), RQP, Internal Product Development Process (IPDP) phase transfer documents, Document Control Revisions (DCRs), etc.)
Supports customer and/or third-party audits as required
May be trained as an auditor and perform quality audits
Identifies staffing requirements, participates in the selection and hiring process; interviews applicants and makes hire recommendations
Provides coaching, feedback, and guidance to team members on a continual basis and takes an active role in developing, monitoring, and updating a career plan for advancement
Completes performance appraisals and reviews with employees; recommends salary increases to management and HR
Provides input to the department budgeting process and monitors and controls expenses through the year to meet budget requirements
Manages other Quality Engineers, to be able to participate in their development and performance reviews
Supports Strategic accounts as assigned and as needed
Qualification
Required
Bachelor's degree in one or more of the following - Life sciences Engineering, Engineering, Quality, Life sciences
5-7 years- including co-op experience
Minimum 3–5 years of direct managerial or supervisory experience, including hiring, coaching, performance management, and team development; proven ability to lead cross-functional teams and drive departmental goals
Experience in life sciences/GMP industry in one or more of the following functions: Quality Assurance, Quality Engineering, Validation, Product Development, Process Engineering or Manufacturing Engineering
Knowledge of applicable regulatory standards, specifically ISO 13485 or possess the ability to understand and enforce the practices
Able to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community
Strong problem solving and analytical skills, with concentration on risk analysis
Demonstrated project organizational skills required
Strong written and verbal communication skills
Ability to apply principles of scientific thinking to a wide range of intellectual and practical problems; deal with nonverbal symbolism (e.g., formulas, scientific equations, graphs); deal with a variety of abstract and concrete variables
Demonstrated ability to participate in and/or lead cross functional teams, ability to independently prioritize and execute projects and responsibilities
Intermediate to advanced knowledge of MS Office Suite and statistical software (e.g., Minitab)
Knowledge of statistics, design of experiments, sampling, gauge R&R, FMEA/risk management, and process control
Excellent customer service focus and professionalism
Strong Supervisory skills
Preferred
Knowledge of FDA Regulation 21 CFR Part 820 preferred but not required
Benefits
Annual Bonuses
Health Insurance: Medical with Rx plan / Dental / Vision
401k (retirement savings) with excellent company match
Company Paid Short-Term and Long-Term Disability
Generous Paid Time off and Holiday Pay
Company
Secant Group
Secant Group, a subsidiary of Solesis, has been partnering with the medical device, pharmaceutical, and aerospace industries for 80 years through cutting-edge design, innovative development, rigorous testing, and manufacturing to develop advanced materials to make your life-changing vision a reality.
51-200 employees
H1B Sponsorship
Secant Group 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 (2)
2023 (1)
Funding
Current Stage
Growth StageTotal Funding
$6MKey Investors
Primus Venture Partners
2000-08-08Series A· $6M
Company data provided by crunchbase