Sedia Biosciences is hiring a QA Director at our Beaverton, Oregon location. At Sedia, we create diagnostic and disease-monitoring products that provide cost effective solutions for rapid, near patient testing. We are currently seeking responsible individuals motivated to help research and develop our future diagnostic products.
Develops GMP policies (in conjunction with Executive Management), plans and directs compliance activities as dictated in Sedia’s Quality Manual. Provides compliance guidance and promotes policy adherence across the organization to ensure products and processes complies with applicable standards and regulations. Coordinates project priorities within the organization and provides oversight of QA project key decisions. Provides metrics to demonstrate functionality of the Quality System on a routine basis to area Managers and Executive Management; Performs activities to meet the production schedule, project timelines and as required by the Quality System (by performing tasks personally or ensuring subordinates and collaborators complete the tasks). Promotes logical approach to quality to encourage individual, self-driven compliance, excellence and effectiveness May be designated Management Representative or back-up to the Management Representative.
Develops and maintains a quality program for the organization that meets or exceeds industry standards and regulations. Develops and presents reports on data/trending to management. Represents the company for all external compliance organizations. Plans and directs activities to meet annual Quality Objectives for the organization. Ensures Quality System and Quality Manual conforms to regulatory requirements and standards. Manages all QA functions and coordinates QA activities to achieve corporate goals.
FLSA Status: Exempt
Reports to: CEO
- Responsible for ensuring compliance to standards and regulations (including developing, implementing, maintaining and monitoring all Quality policies and processes to assure compliance)
- Oversight and management
- Provides oversight for project budgets and monitors expenditures, and optimizes allocated department resources.
- Works with managers, suppliers and contracted organizations to meet Quality Objectives
- Removes barriers to successful implementation and works to resolve them
- Provides strategic direction on specific departmental operations and implements tactical planning
- Routinely interacts with other internal and external management functions (e.g., R&D, Operations, Sales & Marketing, Finance, CMOs, Suppliers).
- Improvement and Trend analysis
- Reviews metrics provided by QA staff, and provides metrics to demonstrate functionality of the Quality System(s) of responsibility on a routine basis to Executive Management and area Managers
- Performs analysis and suggests potential solutions to prevent issues from recurring
- Identifies possible changes to improve efficiency and consistency, and drives Quality Innovation
- May be the designated Management Representative
- Training and Coaching
- Provides company training on compliance topics and ensure organization stays current with industry expectations on·common practices
- Is a consultant to company employees to provide technical expertise on Quality standards and processes
- Promotes logical approach to quality to encourage individual, self-driven compliance, excellence and effectiveness
- Provides strong leadership, mentoring, coaching, counseling and development to staff members.
- Collaborates cross-functionally to implement Quality strategy and objectives.
- Works with leadership to drive culture and change.
- Continuous professional growth and on-going compliance
- Stays current with industry expectations on commons practices through third-party training and/or reading of publications (such as guidance documents)
- Participates on Design Control project team and/or Design Review Board to support new product development activities
- Manages projects to achieve corporate goals and objectives
- Performs activities to meet the production schedule, project timelines and as defined by the Quality System
- Embraces Operation’s Core Values.
- Other duties as may be assigned by supervisor.
- Responsible for QA department including organization development, direction, coordination and evaluation of activities within.
- Carries out supervisory responsibilities in accordance with the policies and applicable laws. Responsibilities include interviewing, hiring, and training employees, planning, assigning, and directing work, appraising performance, rewarding and disciplining employees and addressing complaints and resolving problems.
- Responsible for the organization, development, direction, and evaluation of an Improvement project(s). Leads a multifunctional team and/or team of managers, supervisors, scientists, and technicians within the scope of the responsibilities of the project to accomplish goals.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- B.Sc./M.Sc. in applicable biological science or chemistry with 10+ years’ QA experience for !VD/medical device or related industry OR 15+ year’s QA experience for !VD/medical device or related industry
- Relevant hands-on experience in specific Quality Assurance roles. Experience working under a quality system such as ISO 13485 and/or 21 CFR 820 and/or GLP.
- 3+ years’ experience supervising QA staff.
For consideration, please apply with a resume and cover letter.
Submit your resume and cover letter as an attachment in either RTF, Word, or PDF format to firstname.lastname@example.org.
In the Subject Line of your email, enter: “Your last name, your first name, middle initial (middle initial optional), and Job Title (that you are applying for).” For example, “Smith, Mary, Lab Technician.” If you are applying for multiple positions, please submit separate emails for each position.
Submit your resume and cover letter to the address below. On the mailing address outside, send to the attention of HR indicating the position for which you are applying. You may list multiple positions in the attention line. Only one cover letter/resume needs to be sent if you are applying for multiple positions.
Sedia Biosciences Corp.
Attention: HR (List positions you are applying for, separated by commas, here).
9590 Gemini Drive
Beaverton, OR 97008-7166
ABOUT SEDIA BIOSCIENCES
Sedia is a privately held medical device and diagnostics company founded in 2009 and based in Beaverton Oregon. Sedia is committed to the development of novel epidemiological and diagnostic assays and clinical specimen collection products intended to expand access to healthcare worldwide. For additional information, see our website at www.sediabio.com.